Important Safety Information

INDICATION

Fraxel® Laser Systems are used for dermatological procedures including the following:

Fraxel DUAL® 1550/1927 Laser System:

  • Non-Ablative 1550nm: Procedures to address skin laxity and tone; skin resurfacing procedures; treatment of skin discoloration and lesions, such as, but not limited to age spots, sun spots, actinic keratosis, and melasma; and treatment of wrinkles around the eyes, acne scars, and surgical scars.
  • Non-Ablative 1927nm: Procedures to address skin laxity; treatment of actinic keratosis; treatment of pigmented lesions, specifically age spots, sun spots, and freckles.
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    Fraxel re:pair® SST Laser System/Handpieces:

  • Ablative CO2 Resurfacing (135-μm and 600-μm): Procedures requiring ablation (removal) or resurfacing of the skin, addressing skin laxity and tone, and/or treating wrinkles, rhytids, furrows, fine lines, pigmented lesions, textural irregularities, and skin discoloration.
  • Ablative CO2 Debulking (2-mm and 0.2-mm): Ablation (removal) for the reduction and/or treatment of actinic and seborrheic keratosis (overgrowth of skin), inflammation of the lips, abnormal skin growths, strawberry patches, keloids, birthmarks or abnormal moles, spider veins, rhinophyma (bulb-like, red, swollen nose), syringomas (benign growths usually found around the eyes or upper cheeks), warts, laser incision and/or excision for the performance of upper and lower eyelid blepharoplasty and vermilionectomy (shaving) of the lip.
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    IMPORTANT SAFETY INFORMATION

    Fraxel DUAL 1550/1927 Laser System:

    The following contraindications are routine for many laser treatments and may also be associated with Fraxel DUAL 1550/1927 Laser System treatments. You may not be an appropriate candidate if you:

  • Are predisposed to keloid formation or excessive scarring;
  • Have experienced pigmentation changes following surgery;
  • Have had skin indentations and textural changes following surgery;
  • Are on systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment; or
  • Are undergoing isotretinoin acne treatment or are taking drugs in a similar class.
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    Possible complications from Fraxel DUAL 1550/1927 Laser System treatments include:

  • Blistering and Burns: May develop over the treated areas.
  • Discoloration: The possibility of temporary and permanent skin color change is known to exist with any laser treatment and may occur.
  • Eye Injury: The Fraxel DUAL 1550/1927 Laser System generates an intense beam of laser radiation which may cause injury if not used properly. Protective eyewear or goggles should be worn. It is important to keep the eye protection on at all times during treatment in order to protect your eyes from accidental laser exposure and serious injury.
  • Infection: A risk of infection exists whenever the skin is wounded. The possibility for infection exists even with non-ablative fractional laser devices such the Fraxel.
  • Keloid Formation: A thickened scar can result from excessive growth of fibrous tissue.
  • Prolonged Redness: Mild to moderate transient redness is an expected response. However, if it is severe or persists significantly longer than expected, you should not have another treatment until it goes away.
  • Scarring: The possibility for scarring exists. Local scarring may occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing.
  • Delayed Wound Healing / Skin Textural Changes: Following laser treatment, restoration of the skin may not occur as expected due to your physiology, such as poor wound healing ability or post-treatment care. This may result in undesirable textural changes to the skin.
  • Temporary Bruising: May develop over the treated areas.
  • Have experienced pigmentation changes following surgery;
  • Have had kin indentations and textural changes following surgery;
  • Are on systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment; and
  • Are undergoing isotretinoin acne treatment or are taking drugs in a similar class.
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    Fraxel re:pair SST Laser System/Handpieces:

    The following is a summary of contraindications for Fraxel re:pair SST Laser System treatments. You may not be an appropriate candidate if you:

  • Are predisposed to keloid formation or excessive scarring;
  • Are undergoing isotretinoin treatment or taking drugs in a similar class; or
  • Have active bacterial, viral, or fungal infections.
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    Possible complications from Fraxel re:pair SST Laser System treatments include:

  • Skin discolorations: Post Inflammatory hyperpigmentation (PIH) and hypopigmentation are known complications of many laser treatments such as Fraxel re:pair. In some patients who experience pigment changes, the treated area loses pigmentation (hypopigmentation) and becomes a lighter color than the surrounding skin. This type of reaction may also be permanent.
  • Keloid Formation: A thick scar resulting from excessive growth of fibrous tissue.
  • Scarring: Local scarring may occur directly from laser exposure if treatment procedures are not followed properly, or from infection or physical irritation such as picking and rubbing. Avoid contact with clothing following treatment to minimize the risk of abrasion. Scarring in the area of the eye could lead to turning out of the eyelid such that the inner surface is exposed.
  • Eye Injury: You should wear proper eye protection throughout the procedure.
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    Talk to your doctor for more information about Fraxel.