El.En Electronic Engineering Spa
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
ERISE 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.
ERISE 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.
ERISE is an Erbium:YAG laser handpiece delivering laser radiation at 2940nm. It is intended to be used with DEKA LUXEA platform, cleared by FDA with K192539. The Erise laser handpiece includes: A connector to connect to the console, A cord where electrical cables and hydraulic tubes pass in, A plastic shell, A Laser cavity, A mechanical shutter, An optical guide, An ending tip which provides different spot sizes (diameter 2, 4, 9mm), including microbeam output (diameter 9mm). The 2940 nm Erbium:YAG laser handpiece is controlled by the DEKA LUXEA console which it is connected to, through the connector.
Summary parsed at:2026-06-01 05:41:35 UTC
