# K050069: Cutera Flashlamp Tabletop Aesthetic Product

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Jan 31, 2005 after 19 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: 8 generations back to K910422 (1992). 47 ancestors in all.
No later device cites it as a predicate yet.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K042165: Cutera Tabletop Aesthetic Product, Cutera, Inc. (2004) Summary page 1.

## Indications for use
The Cutera Flashlamp Tabletop Aesthetic Product is intended for the treatment of benign pigmented lesions.

Source page: https://510kreport.com/device/K050069
Methodology: https://510kreport.com/methodology