Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
2940 nm Er:Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.
2940 nm Er:Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars). With microbeam end piece it is indicated for Skin resurfacing.
2940nm Er:YAG handpiece is the same as the one cleared with Quanta Forte platform (K152714), with the addition of a microbeam end piece. 2940nm Er:YAG is a handpiece that can work in conjunction with Quanta System FDA cleared devices (Quanta Forte and EVO and Discovery Pico Platform) provided with a suitable connector for recognizing and controlling the handpiece. Its emission is triggered by means of a footswitch connected to the console of the device it is used with.
Summary parsed at:2026-06-01 06:01:08 UTC
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
ERISE Laser handpiece
Chrome
Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V
Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
Pastelle Pro
6 submissions cite K173002 as a predicate
