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.
Improper use of Fraxel® may cause personal injury or damage to the system. See the Operator Manual for detailed directions, proper use, and full risk and safety information.
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.