Manufacturer
El.En Electronic Engineering SpaERISE Laser handpiece
El.En Electronic Engineering Spa
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K202258
- Device name
- ERISE Laser handpiece
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-08-10
- Decision date
- 2021-04-26
- Submission type
- Traditional
- Technology type
- Er:YAG(AI inferred)
- Clinical applications
- Skin resurfacingVascular treatmentAcne treatment
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
22940 nm Er:Yag Laser Handpiece
Deka Luxea
K202258 references 2 predicate/reference devices
Cited as predicate
1Dermablate
1 submission cite K202258 as a predicate