# K202258: ERISE Laser handpiece

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Apr 26, 2021 after 259 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: 23 generations back to K943450 (1995). 549 ancestors in all.
No later device cites it as a predicate yet.
0 of 550 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173002: 2940 nm Er:Yag Laser Handpiece, Quanta System Spa (2017) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K202258
Methodology: https://510kreport.com/methodology