Device Dossier
Skin surface treatment system applicator, laser
Device Dossier for Skin surface treatment system applicator, laser (Skin surface treatment system applicator, laser, Class IIb, sponsor Ellex Medical).…
- GMDN category: Skin surface treatment system applicator, laser
Intended purpose
The device is designed for cutaneous laser treatment. -The 1550 nm is indicated for dermatological procedures that require soft tissue coagulation, such as skin resurfacing treatment. The 1550nm can be used to treat dyschromia and cutaneous lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), actinic keratosis, and melasma, and for treatment of periorbital wrinkles, acne scars and surgical scars. -The 1927 nm is indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephelides (freckles).