# K070138: Cutera ER:Yag Laser Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Mar 27, 2007 after 70 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: 10 generations back to K910422 (1992). 233 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 235 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 1.
- K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System, Medical Laser Technologies, LLC (2003) Summary page 1.

## Most influential descendants
- K073158: Sculpture 2.94 ER:Yag System (2008), 0 descendants of its own

## Indications for use
The Cutera Er:YAG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue. Indications include: treatment of wrinkles and skin resurfacing.

Source page: https://510kreport.com/device/K070138
Methodology: https://510kreport.com/methodology