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. For additional product information see www.fraxel.com.
CAUTION: Federal (USA) law restricts this device to the sale by or on the order of a physician.