# K080530: Modification to Cutera ER:Ysgg Laser Handpiece

- Pathway: 510(k) (Special)
- Applicant: Cutera, Inc.
- Decided: Aug 15, 2008 after 171 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: 11 generations back to K910422 (1992). 243 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 245 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063867: Cutera ER:Ysgg Laser Handpiece, Cutera, Inc. (2007) Summary page 1.

## Most influential descendants
- K210183: Waterlase iPLus (2022), 0 descendants of its own

## Indications for use
The Cutera Er:YSGG laser hand piece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. Dermatology and Plastic Surgery Indications include: treatment of wrinkles and skin resurfacing Opthalmology Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit. The Cutera Fractionated Er:YSGG laser hand piece is designed for use in dermatology for skin resurfacing and for coagulation.

Source page: https://510kreport.com/device/K080530
Methodology: https://510kreport.com/methodology