INDICATION

• The Fraxel^® 1550, Fraxel^® 1927, and Fraxel^® DUAL 1550/1927 laser systems are cleared for the following indications for use:
  • Fraxel^® 1550nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; skin resurfacing procedures; treatment of dyschromia and cutaneous lesions, such as, but not limited to lentigos, solar lentigos, actinic keratosis, and melasma; and treatment of periorbital wrinkles, acne scars and surgical scars.
  • Fraxel^® 1927nm wavelength is indicated for dermatological procedures requiring the coagulation of soft tissue; treatment of actinic keratosis; treatment of pigmented lesions, specifically age spots, sun spots and ephiledes.

IMPORTANT SAFETY INFORMATION

• The following is a summary of contraindications for Fraxel^® 1550, Fraxel^® 1927 and Fraxel^® DUAL 1550/1927 laser systems treatments. Pre-screening should include, but not be limited to:
  • Predisposition to keloid formation or excessive scarring;
  • Pigmentation changes following surgery;
  • Skin indentations and textural changes following surgery;
  • Systemic steroids (e.g. prednisone, dexamethasone), which should be rigorously avoided prior to and throughout the course of treatment; and
  • Patients undergoing isotretinoin acne treatment or with drugs in a similar class.

• Do not use Fraxel^® 1550, Fraxel^® 1927, and Fraxel^® DUAL 1550/1927 on any patient who is ineligible for general surgery.
• The Fraxel^® 1550, Fraxel^® 1927 and Fraxel^® 1550/1927 DUAL generate a Class 4 laser. Protective eyewear or goggles should be worn by any operator and assistant.