Device Dossier
Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
Device Dossier for Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system (Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system, Class IIb,…
- GMDN category: Dermatological Nd:YAG/frequency-doubled Nd:YAG laser system
Intended purpose
TRI-BEAM is indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic, and general surgical procedures for coagulation and hemostasis. 523nm wavelength (nominal delivered energy of 585nm and 650nm with optional dye handpieces): tattoo removal: light ink (red, tan, purple, orange, sky blue, green); removal of epidermal pigmented lesions, removal of minor vascular lesions including but not limited to telangiectasias; treatment of lentigines; of cafe-au-lait; of seborrheic keratoses; of post inflammatory hyper-pigmentation; of becker's nevi, freckles, and nevi spilus. 1064nm wavelength: tattoo removal: dark ink (black, blue, and brown); removal of nevus of ota; removal or lightetning of unwanted hair with or without adjuvant preparation; treatment of common nevi; skin resurfacing procedures for the treatment of acne scars and wrinkle