Cutera Devices Usage & Safety Guide

Indications for Use: AviClear is indicated for the treatment of acne vulgaris, the treatment of acne scars, and the treatment of sebaceous hyperplasia.

Contraindications: Pregnant patients and patients undergoing treatment for skin cancer.

Important Safety Information: The following treatment-related side effects may occur during or after treatment with AviClear: Discomfort, erythema and edema, transient acne flareups, temporary skin dryness, blisters, crusting/Scabbing, hyperpigmentation, skin texture changes, infection, scarring, hypopigmentation and altered hair growth.

Warnings: Do not use topical anesthetic with AviClear treatments;do not treat over dysplastic nevi or questionable pigmented lesions; do not treat over or close to tattoos or permanent make-up.

Precautions: Use caution when treating patients with any of the following: current or recent use of Isotretinoin (Accutane/Roaccutane), current or recent use of anticoagulants, presence of any inflammatory skin condition other than acne in the target area, history of malignant tumors in the target area, history of coagulopathies, history of keloids or hypertrophic scarring, history of vitiligo or pigmentary disorders, history of herpes – pre-treatment with an antiviral may be indicated, open lesions or wounds – treatment should only be performed on intact skin, metal or electronic implants – reaction to treating over implants is unknown; check with implant manufacturer or physician managing the implant before treating. The AviClear Laser System has not been studied on the lips, upper and lower eyelids, and eyebrows. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: The truSculpt skin contouring system uses RF energy that is intended to generate heat deep within body tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of fat removal, skin regrowth and tightening; and to temporarily relieve pain.

IMPORTANT SAFETY INFORMATION: Expected Transient Events and Possible Adverse Effects: bleeding; bruising; blistering; burns; crusting; discomfort and pain; increased vascularization of the treatment area; infection; lumps; numbness; redness (erythema); scabs; scarring; skin color changes; swelling (edema); tenderness.

Contraindications: infection in the target area; history of poor wound healing; history of keloid formation; pregnancy; cardiac pacemakers or internal defibrillators; malignant or benign tumors in the target area; multiple sclerosis; arteriosclerosis or weakened blood vessels; history of hemophilia or bleeding disorders; thrombosis or thrombophlebitis, either acute or sub-acute. In addition, the device should not be used to treat over the following areas: over implanted devices, including metallic implants, electronic implants, time-released medical implants, and superficially placed body contouring implants; on the head; near or over the eyes; near or over the ears; transcerebrally; on the neck; over the carotid sinus; over the trachea or thyroid cartilage; near or over the heart; near or over reproductive organs; directly over the spinal column; over healing fractures or bone growth areas; places where the skin suffers from any sensory impairment; over the ischemic tissues in individuals with vascular disease where the blood supply would be unable to follow the increase in metabolic demand.

PRECAUTIONS: Ensure that there is a minimum of 1 cm thickness of soft tissue in the treatment area to allow for current delivered through the skin to disperse. Do not use RF energy over: hard structures including bone or cartilage unless there is at least 1 cm thickness of soft tissue between the electrode and the hard structure; joint replacements viscera (stomach, spleen liver); joint capsules in acute or sub-acute arthritic conditions. Diabetes – may impede wound healing.

Indications for Use: truFlex is indicated for muscle strengthening, toning, and firming.

Important Safety Information: Expected Transient Events and Possible Adverse Effects: Increased heart rate – This procedure has a risk of increasing patient’s heart rate. Skin irritation/hypersensitivity – Some patients may experience skin irritation or hypersensitivity due to the electrical stimulation or electrical conductive medium. Allergic skin reaction – Skin irritation may also cause a possible allergic skin reaction. Tingling – May occur in the treatment area. Discomfort/pain and muscle soreness – Moderate discomfort during treatment is expected. Some discomfort, tenderness, and muscle soreness in the treatment area may persist for a few hours following treatment, potentially extending to a few days. Bruising – May occur in the treatment area. Burns – Burns beneath the electrodes have been reported with the use of powered muscle stimulators. Random muscle contraction – May be experienced after the procedure. Frequent urination/bowel stimulation – May be caused by the procedure. Increased hunger – Increase in metabolic rate results in feeling hungry more frequently.

Contraindications for Use: truFlex is contraindicated for patients with: cardiac pacemakers, defibrillators, or other implanted electronic devices; metallic implants under the treatment area; epilepsy; cancerous lesions; acute trauma or fracture; recent surgical procedures; abdominal or inguinal hernia; critical ischemia of lower limbs; blood flow deficiencies/venous thrombosis.

Warnings: Do not treat pregnant patients without physician evaluation. Safety of stimulation during pregnancy or delivery has not been established. Do not treat patients with known myocardial arrhythmia without physician evaluation. Do not treat patients who have chronic conditions in the abdomen, gut, or intestinal areas (e.g., Crohn’s disease, colitis, Graves’ disease) without physician evaluation. Do not treat the eye area. Do not treat over the carotid sinus nerves, particularly in patients with a known sensitivity to the carotid sinus reflex. Do not treat transthoracically. The introduction of electrical current into the heart may cause cardiac arrhythmia. Do not treat transcerebrally. Do not treat over the neck and mouth. Severe spasming of the laryngeal and pharyngeal muscles may occur, closing the airway and causing difficulty breathing. Do not treat over swollen, infected, or inflamed areas or skin eruptions (e.g., phlebitis, thrombophlebitis, varicose veins). Do not treat over metal implants. Powered electrical stimulators should be kept out of the reach of children.

Indications for Use: The excel V+ is indicated for: treatment of benign vascular lesions including, but not limited to,telangiectasia, angiomas, port wine stains, diffuse redness, poikiloderma ofcivatte, rosacea, leg veins, periocular veins, venous lakes, and hemangiomas; treatment of benign pigmented lesions including, but not limited to, senile and solar lentigines, dermatosis papulose nigra, ephelides, dyschromia, and nevi; treatment of benign cutaneous lesions including, but not limited to, wrinkles, verrucae, seborrheic keratoses, acne scars, skin tags, erythematous scars, bruising, and mild to moderate acne vulgaris; hair removal; treatment of pseudofolliculitis barbae.

Important Safety Information: The following treatment-related expected transient side effects and possible adverse events may occur during or following treatment with excel V+: Erythema, edema and purpura may occur following treatment and typically resolve with time. Hyperpigmentation, hypopigmentation, burns, erosion, epidermal crusting, or blistering may occur, some of which may result in scarring. Deep tissue injury and prolonged wound healing may occur when treating warts; Temporary or permanent gray hair (leukotrichia) may develop; Stimulation of terminal hair growth may occur within or adjacent to treated area; Undesired hair loss in hair-bearing areas may result from treatment of vascular lesions; Sun exposure, tanning beds, and artificial tanning may increase the risk of side effects and adverse events. Red rash/bumps; Hemosiderin staining; Textural changes/cutaneous indentations.

Contraindications: Pregnant patients; patients undergoing treatment for skin cancer.

Warnings: Do not treat over dysplastic nevi or questionable pigmented lesions. Do not treat over or close to tattoos or permanent make-up. Hair removal by lasers can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.

Preautions: Photosensitizing drugs (Tetracyclines, etc.); Anticoagulants – may increase risk of purpura or bruising; History of coagulopathies; History of keloids or hypertrophic scarring; Diabetes – may impede wound healing; History of herpes – pre-treatment with an antiviral may be indicated; Isotretinoin (Accutane) use within the previous 6 months; History of vitiligo. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: The xeo+ 1064 nm is indicated for: removal of unwanted hair; stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles; treatment of pseudofolliculitis barbae (PFB); treatment of benign vascular lesions such as, but not limited to, hemangiomas, port wine stains, telangiectasias, rosacea, venous lakes, leg veins, spider veins and poikiloderma of Civatte; treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles; reduction of red pigmentation in hypertrophic scars where vascularity is an integral part of the scar; treatment of warts; treatment of mild to moderate inflammatory acne vulgaris.

Contraindications:pregnant patients; patients undergoing treatment for skin cancer.

Important Safety Information: Expected Transient Events and Possible Adverse Effects: DISCOMFORT/PAIN – Some discomfort may be experienced during treatment. Pain may include the feeling of burning, stinging, and radiating pain. REDNESS/SWELLING – Short term redness (erythema) is common, and swelling (edema) of the treated area may occur. An urticarial (hive-like) reaction may occur with smaller vessels. PURPURA/BRUISING – Purpura (bruising) is a transient phenomenon that usually resolves with time. ITCHING/DRY SKIN – Treatment may result in itching and/or dry skin. RED RASH/BUMPS – Red rash/bumps may appear after treatment. This resolves with time. HEMOSIDERIN STAINING – Hemosiderin staining (iron leaking into tissue from blood breakdown) may occur and usually resolves over time; however, it may be permanent. HYPOPIGMENTATION/ HYPERPIGMENTATION – During the healing process, there is a slight possibility that the treated area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may be permanent. EPIDERMAL CRUSTING – Pigmented lesions may crust as part of the healing process. Epidermal crusting may develop over vascular lesions. It is important not to disturb the crusts. Crusts will typically slough 7 to 14 days after treatment but may require medication if sensitivity or redness occurs. WOUNDS – Treatment can result in burning, blistering, or bleeding of the treated areas. When treating warts, deep tissue injury and prolonged wound healing may also occur. INFECTION – Infection is a rare possibility whenever the skin surface is disrupted, though proper wound care should prevent this. If signs of infection develop, such as pain, heat or surrounding redness, the patient should be advised to contact their treatment provider. SCARRING – Scarring is a rare occurrence, but it is a possibility if the skin’s surface is disrupted. To minimize the chances of scarring, it is important to advise patients to follow all post-treatment instructions.TEXTURAL CHANGES/CUTANEOUS INDENTATIONS – Textural changes and/or cutaneous indentations may occur as a result of heat diffusion and thermal injury to tissue surrounding vessels. UNDESIRABLE HAIR REDUCTION – Hair reduction may occur at treatment sites not intended for hair reduction, such as during vascular or laser genesis treatments. This is usually temporary but may be permanent. PARADOXICAL HAIR GROWTH – Stimulation of terminal hair growth following photo- epilation may occur within or adjacent to the treated area. LEUKOTRICHIA – Temporary or permanent leukotrichia (localized white or gray hair) may occur.

Warnings: Do not treat over dysplastic nevi or questionable pigmented lesions. Do not treat over open wounds. Do not treat over or close to tattoos or permanent make-up. Do not treat over or close to metal or electronic implants. Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.

Precautions: Use caution when treating patients with any of the following: History of coagulopathies;History of keloids or hypertrophic scarring; History of herpes – pre-treatment with an antiviral may be indicated History of vitiligo – may cause de-pigmentation; Diabetes – may impede wound healing Metal or electronic implants; Current or recent use of the following medications: Accutane – do not treat if taken in the past 6 months; Gold Therapy – may cause blue-gray discoloration; Anticoagulants – may increase risk of purpura or bruising; Photosensitizing medications/agents. In addition, observe the following precautions: Use caution when treating over hair bearing areas. Laser energy may affect hair growth.Place moist gauze between the lips and teeth if treating near the mouth. Laser energy may affect teeth. Treat at least at least 15 cm (6 in) frompacemakers/ defibrillators. Reaction to metal or electronic implants is unknown. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: The excel HR 755 nm is indicated for: treatment of unwanted hair; long term or permanent hair reduction; treatment of benign pigmented lesions; treatment of benign vascular lesions. The excel HR 1064 nm is indicated for: treatment of unwanted hair; long term or permanent hair reduction; treatment of pseudofolliculitis barbae (PFB); treatment of benign vascular lesions; treatment of benign cutaneous lesions; treatment of wrinkles.

Contraindications: Pregnant patients; patients undergoing treatment for skin cancer.

Important Safety Infromation: Expected Transient Events and Possible Adverse Effects; Erythema, edema, and purpura may occur following treatment and typically resolve with time; Hyperpigmentation, hypopigmentation, burns, erosion, epidermal crusting, or blistering may occur, some of which may result in scarring; Deep tissue injury and prolonged wound healing may occur when treating warts; Temporary or permanent gray hair (leukotrichia) may develop; Stimulation of terminal hair growth may occur within or adjacent to treated area; Undesired hair loss in hair-bearing areas may result from treatment of vascular lesions; Sun exposure/tanning beds/artificial tanning may increase the risk of unwanted side effects and adverse events. Red rash/bumps; Hemosiderin staining; Textural changes/cutaneous indentations.

Warnings: Do not treat over dysplastic nevi or questionable pigmented lesions. Do not treat over or close to tattoos or permanent make-up. Hair removal by lasers can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern and South Asian heritage treated on the face and neck.

Precautions: Photosensitizing drugs (Tetracyclines, etc.); Anticoagulants – may increase risk of purpura or bruising; History of coagulopathies; History of keloids or hypertrophic scarring; Diabetes – may impede wound healing; History of herpes – pre-treatment with an antiviral may be indicate; Isotretinoin (Accutane) use within the previous 6 months; History of vitiligo. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: enlighten III indciated for: tattoo removal; treatment of benign pigmented lesions; treatment of acne scars and wrinkles.

Contraindications: Pregnant patients; Patients undergoing treatment for skin cancer; Dysplastic nevi; Accutane if taken in the prior 6 months; Gold Therapy; Photosensitizing drugs (Tetracycline, etc); Bleeding disorders or history of coagulopathies; Wound infections; Open lesions.

Important Safety Information: Expected Transient Events and Possible Adverse Effects: The procedure may result in the following adverse experiences or risks. This list may not include all possible risks. Discomfort. Mild discomfort is typical during the treatment of benign pigmented lesions. For tattoo removal treatments, where higher settings are typically used, moderate to significant discomfort is frequently reported. Most patients describe the discomfort as less than when the tattoo was applied. Some areas are more sensitive than others. Topical and local anesthetic options may be available if required. Immediate ashy change in benign pigmented lesions. Epidermal benign pigmented lesions will frost during treatment and then develop a thin gray crust, which sloughs 5-21 days after treatment. When the crust sloughs, the skin in the place of the treated lesions may appear lighter than the surrounding untreated skin. Hyperpigmentation. Brown darkening of the skin can occur as a result of the laser light or of the inflammation during healing. It may not appear immediately and may be seen a few weeks after treatment. Therefore, it is advisable to space treatments by several weeks. Hyperpigmentation is more likely to develop in darker or tanned skin, and it may be visible longer in darker skin or with sun exposure. Although it may last for some months, hyperpigmentation is often not permanent; this differs from hypopigmentation (loss of pigment), which in some cases can be permanent.Hypopigmentation. Lightening of the skin in the place of the treated lesion and around it is an anticipated adverse event in laser treatment of pigmented lesions. In clinical studies in which benign pigmented lesions were treated, hypopigmentation was observed in approximately 30% of subjects at 6 weeks and in some cases was observed at 12 week follow-up. Longer follow-up data is not available for resolution of hypopigmentation in these subjects. Petechiae and purpura. Pinpoint bleeding may occur at the treatment site and should resolve within 1-2 hours. The pinpoint blood should slough with the thin crusts above. Mild bruising may be evident in the skin surrounding the treated lesion in some cases. Blisters, oozing lasting more than one day, or bleeding lasting more than a few hours should be evaluated by the treating physician.Edema and erythema. Swelling (edema) and redness (erythema) often occur and may last a few days. Application of cold packs immediately after treatment may reduce these. Swelling that develops after a few days, especially if accompanied by new warmth or redness, should be evaluated. Allergic reaction. Patients who have had a prior allergic reaction to ink during tattoo application may have a similar reaction after laser treatment. Bullae/scabs/crusting. These may occur following tattoo treatment and usually take 4-10 days to heal. Texture changes. Transient texture changes are often noted but usually resolve with time. Infection. Despite good wound care, pain, swelling, oozing, and fever can indicate the development of an infection. Topical and/or oral antibiotics may be necessary. Scarring. Scarring is a rare occurrence, but it is a possibility if the skin’s surface is disrupted. To minimize the chances of scarring, it is important that patients follow all post-treatment instructions provided by their healthcare provider. Good post-treatment care can help reduce the possibility of scarring. Persistence of pigmented lesion. Multiple treatments are common, and complete clearing is not always possible. Incomplete tattoo removal. Multiple treatments are required, and complete clearing is not always possible. Not all ink colors and compositions will respond to tattoo removal treatment. Paradoxical darkening or color change. Some tattoo inks, including many lighter and skin- tone inks, may darken or change color in response to treatment. “Bleeding” of ink into surrounding skin. May result in smudging or loss of definition of a tattoo rather than removal.

Warnings: Do not treat or treat over dysplastic nevi or questionable pigmented lesions. Only benign pigmented lesions are treatable. Accurate pre-operative diagnosis is very important to prevent treatments on malignant lesions.

Precautions: Current medications (both routine and occasional use); Accutane – do not treat if taken in the last 6 months; Gold Therapy – may cause blue-gray discoloration; Photosensitizing drugs (Tetracycline, etc) – perform test spots and adjust parameters accordingly; Anticoagulants – may increase risk of purpura or bruising; Bleeding disorders; Vitiligo or history of pigmentary disorders, particularly tendency for hyper- or hypopigmentation; Herpes – heat from the treatment could induce a flare-up; pretreatment with an antiviral may be indicated; Wound infections; Open lesions – treatments should only be performed on intact, healthy skin; History of coagulopathies; History of keloid or hypertrophic scarring; Diabetes – may impede wound healing; History of seizure disorders due to light. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: The Acutip handpiece is indicated for: treatment of vascular lesions; treatment of benign pigmented lesions.

Contraindications: Pregnant patients; patients undergoing treatment for skin cancer.

Important Safety Infromation: Expected Transient Events and Possible Adverse Effects DISCOMFORT/PAIN – Some discomfort may be experienced during treatment. Pain may include the feeling of burning, stinging, and radiating pain. REDNESS/SWELLING – Short term redness (erythema) is common, and swelling (edema) of the treated area may occur. An urticarial (hive-like) reaction may occur with smaller vessels. PURPURA/BRUISING – Purpura (bruising) is a transient phenomenon that usually resolves with time. HEMOSIDERIN STAINING – Hemosiderin staining (iron leaking into tissue from blood breakdown) may occur and usually resolves over time; however, it may be permanent. HYPOPIGMENTATION/HYPERPIGMENTATION – During the healing process, there is a slight possibility that the treated area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may be permanent. EPIDERMAL CRUSTING – Pigmented lesions may crust as part of the healing process. Epidermal crusting may develop over vascular lesions. It is important not to disturb the crusts. Crusts will typically slough 7 to 14 days after treatment but may require medication if sensitivity or redness occurs. WOUNDS – Treatment can result in burning, blistering, or bleeding of the treated areas. INFECTION – Infection is a rare possibility whenever the skin surface is disrupted, though proper wound care should prevent this. If signs of infection develop, such as pain, heat or surrounding redness, the patient should be advised to contact their treatment provider. SCARRING – Scarring is a rare occurrence, but it is a possibility if the skin’s surface is disrupted. To minimize the chances of scarring, it is important to advise patients to follow all post-treatment instructions. TEXTURAL CHANGES/CUTANEOUS INDENTATIONS – Textural changes and/or cutaneous indentations may occur as a result of heat diffusion and thermal injury to tissue surrounding vessels. UNDESIRABLE HAIR REDUCTION – Hair reduction may occur at treatment sites. This is usually temporary but may be permanent.

Warnings: Do not treat over dysplastic nevi or questionable pigmented lesions. Do not treat over open wounds.Do not treat over or close to tattoos or permanent make-up.

Precautions: Use caution when treating patients with any of the following: History of coagulopathies; History of keloids or hypertrophic scarring; History of herpes – pre-treatment with an antiviral may be indicated History of vitiligo – may cause de-pigmentation; Diabetes – may impede wound healing; Current or recent use of the following medications: Accutane – do not treat if taken in the past 6 months Gold Therapy – may cause blue-gray discoloration; Anticoagulants – may increase risk of purpura or bruising; Photosensitizing medications/agents. In addition, observe the following precautions: Treat at least at least 15 cm (6 in) from pacemakers/defibrillators. Reaction to metal or electronic implants is unknown. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: The Prowave handpiece is indicated for: removal of unwanted hair from skin types I-IV; stable long-term, or permanent, hair reduction.

Contraindications: Pregnant patients; patients undergoing treatment for skin cancer.

Important Safety Infromation: Expected Transient Events and Possible Adverse Effects: DISCOMFORT/PAIN – Some discomfort may be experienced during treatment. Pain may include the feeling of burning, stinging, and radiating pain. REDNESS/SWELLING – Short term redness (erythema) is common, and swelling (edema) of the treated area may occur. An urticarial (hive-like) reaction may occur with smaller vessels. PURPURA/BRUISING – Purpura (bruising) is a transient phenomenon that usually resolves with time. HYPOPIGMENTATION/ HYPERPIGMENTATION – During the healing process, there is a slight possibility that the treated area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may be permanent. WOUNDS – Treatment can result in burning, blistering, or bleeding of the treated areas. INFECTION – Infection is a rare possibility whenever the skin surface is disrupted, though proper wound care should prevent this. If signs of infection develop, such as pain, heat or surrounding redness, the patient should be advised to contact their treatment provider. SCARRING – Scarring is a rare occurrence, but it is a possibility if the skin’s surface is disrupted. To minimize the chances of scarring, it is important to advise patients to follow all post-treatment instructions. PARADOXICAL HAIR GROWTH – Stimulation of terminal hair growth following photo- epilation may occur within or adjacent to the treated area. LEUKOTRICHIA – Temporary or permanent leukotrichia (localized white or gray hair) may occur.

Warnings: Do not treat over dysplastic nevi or questionable pigmented lesions. Do not treat over open wounds. Do not treat over or close to tattoos or permanent make-up.

Precautions: Use caution when treating patients with any of the following: History of coagulopathies; History of keloids or hypertrophic scarring; History of herpes – pre-treatment with an antiviral may be indicated History of vitiligo – may cause de-pigmentation; Hormone disorders (e.g., Polycystic Ovarian Syndrome) – may not see effective hair reduction; Diabetes – may impede wound healing; Current or recent use of the following medications: Accutane – do not treat if taken in the past 6 months; Gold Therapy – may cause blue-gray discoloration; Anticoagulants – may increase risk of purpura or bruising; Photosensitizing medications/agents. In addition, observe the following precaution: Treat at least at least 15 cm (6 in) from pacemakers/defibrillators. Reaction to metal or electronic implants is unknown. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: The Limelight handpiece is indicated for treatment of benign pigmented lesions; treatment of vascular lesions.

Contraindications: Pregnant patients; patients undergoing treatment for skin cancer.

Important Safety Information: Expected Transient Events and Possible Adverse Effects: DISCOMFORT/ PAIN – Some discomfort may be experienced during treatment. Pain may include the feeling of burning, stinging and radiating pain. REDNESS/SWELLING – Short term redness (erythema) or swelling (edema) of the treated area is common and may occur. An urticarial (hive-like) reaction may occur with smaller vessels. PURPURA/BRUISING – Purpura (bruising) is a transient phenomenon that usually resolves with time. HEMOSIDERIN STAINING – Hemosiderin staining (iron leaking into tissue from blood breakdown) may occur and usually resolves over time; however, it may be permanent. HYPOPIGMENTATION/HYPERPIGMENTATION – During the healing process, there is a possibility that the treated area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may be permanent. EPIDERMAL CRUSTING – Pigmented lesions may crust as part of the healing process. Epidermal crusting may develop over vascular lesions. It is important not to disturb the crusts. Crusts will typically slough 7 to 14 days after treatment but may require medication if sensitivity or redness occurs. WOUNDS – Treatment can result in burning, blistering, or bleeding of the treated areas. INFECTION – Infection is a rare possibility whenever the skin surface is disrupted, though proper wound care should prevent this. If signs of infection develop, such as pain, heat or surrounding redness, the patient should be advised to contact their treatment provider. SCARRING – Scarring is a rare occurrence, but it is a possibility if the skin’s surface is disrupted. To minimize the chances of scarring, it is important to advise patients to follow all post-treatment instructions. TEXTURAL CHANGES/CUTANEOUS INDENTATIONS – Textural changes and/or cutaneous indentations may occur as a result of heat diffusion and thermal injury to tissue surrounding vessels. UNDESIRABLE HAIR REDUCTION – Hair reduction may occur at treatment sites. This is usually temporary but may be permanent.

Warnings: Do not treat over dysplastic nevi or questionable pigmented lesions. Do not treat over open wounds.Do not treat over or close to tattoos or permanent make-up.

Precautions: Use caution when treating patients with any of the following: History of coagulopathies; History of keloids or hypertrophic scarring; History of herpes – pre-treatment with an antiviral may be indicated History of vitiligo – may cause de-pigmentation; Diabetes – may impede wound healing; Current or recent use of the following medications: Accutane – do not treat if taken in the past 6 months; Gold Therapy – may cause blue-gray discoloration; Anticoagulants – may increase risk of purpura or bruising; Photosensitizing medications/agents. In addition, observe the following precaution: Treat at least at least 15 cm (6 in) from pacemakers/defibrillators. Reaction to metal or electronic implants is unknown. Refer to the Operator Manual to view the laser safety labels of the product.

Indications for Use: xeo+ 1064 nm Nd:YAG is indicated for: removal of unwanted hair; stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles; treatment of pseudofolliculitis barbae (PFB); coagulation and hemostasis of benign vascular lesions such as, but not limited to, hemangiomas, port wine stains, telangiectasias, rosacea, venous lakes, leg veins, spider veins and poikiloderma of Civatte; treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles; reduction of red pigmentation in hypertrophic scars where vascularity is an integral part of the scar; treatment of warts; treatment of mild to moderate inflammatory acne vulgaris.

Contraindications: Pregnant patients; patients undergoing treatment for skin cancer.

Important Safety Information: Expected Transient Events and Possible Adverse Effects: DISCOMFORT/PAIN – Some discomfort may be experienced during treatment. Pain may include the feeling of burning, stinging, and radiating pain. REDNESS/SWELLING – Short term redness (erythema) is common, and swelling (edema) of the treated area may occur. An urticarial (hive-like) reaction may occur with smaller vessels. PURPURA/BRUISING – Purpura (bruising) is a transient phenomenon that usually resolves with time. ITCHING/DRY SKIN – Treatment may result in itching and/or dry skin. RED RASH/BUMPS – Red rash/bumps may appear after treatment. This resolves with time. HEMOSIDERIN STAINING – Hemosiderin staining (iron leaking into tissue from blood breakdown) may occur and usually resolves over time; however, it may be permanent. HYPOPIGMENTATION/ HYPERPIGMENTATION – During the healing process, there is a slight possibility that the treated area may become either lighter (hypopigmentation) or darker (hyperpigmentation) in color compared to the surrounding skin. This is usually temporary, but, on a rare occasion, it may be permanent.

Warnings: Do not treat over dysplastic nevi or questionable pigmented lesions. Do not treat over open wounds. Do not treat over or close to tattoos or permanent make-up. Do not treat over or close to metal or electronic implants. Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals. Based upon currently available data, the highest risk groups for this response are females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.

Precautions: Use caution when treating patients with any of the following: History of coagulopathies; History of keloids or hypertrophic scarring; History of herpes – pre-treatment with an antiviral may be indicated History of vitiligo – may cause de-pigmentation; Diabetes – may impede wound healing Metal or electronic implants; Current or recent use of the following medications: Accutane – do not treat if taken in the past 6 months; Gold Therapy – may cause blue-gray discoloration; Anticoagulants – may increase risk of purpura or bruising; Photosensitizing medications/agents. In addition, observe the following precautions: Use caution when treating over hair bearing areas. Laser energy may affect hair growth. Place moist gauze between the lips and teeth if treating near the mouth. Laser energy may affect teeth. Treat at least at least 15 cm (6 in) from pacemakers/defibrillators. Reaction to metal or electronic implants is unknown. Refer to the Operator Manual to view the laser safety labels of the product.