Manufacturer
Quanta System Spa2940 nm Er:Yag Laser Handpiece
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
- K173002
- Device name
- 2940 nm Er:Yag Laser Handpiece
- Company
- Quanta System Spa
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-09-27
- Decision date
- 2017-12-13
- 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
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.
Intended Use
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.
Device Description
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
Predicate devices
3—
—
Not ingested
MicroSpot Handpiece
Quanta Forte
K173002 references 3 predicate/reference devices
Cited as predicate
6Discovery 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