# K173002: 2940 nm Er:Yag Laser Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Dec 13, 2017 after 77 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 548 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 550 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152714: Quanta Forte, Quanta System Spa (2015) Summary page 4.
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece, Fotona D.D. (2014) Summary page 4.
- K152153: MicroSpot Handpiece, Asclepion Laser Technologies GmbH (2015) Summary page 4.

## Most influential descendants
- K202258: ERISE Laser handpiece (2021), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K173002
Methodology: https://510kreport.com/methodology