# K063867: Cutera ER:Ysgg Laser Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Mar 27, 2007 after 88 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). 242 ancestors in all.
2 later devices descend 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)
- K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 1.
- K052354: Oculase MD, Biolase Technology, Inc. (2006). Our reading of the summary gave K062354, FDA’s number for Vectra Genisys VMS FR (Encore Medical L.P.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioLase Oculase MD”.
- K032599: Medical Laser Technologies, LLC MTL Erbium:Yag Laser System, Medical Laser Technologies, LLC (2003) Summary page 1.
- K031140: Waterlase, Biolase Technology, Inc. (2004) Summary page 1.

## Most influential descendants
- K080530: Modification to Cutera ER:Ysgg Laser Handpiece (2008), 1 descendant of its own
- K210183: Waterlase iPLus (2022), 0 descendants of its own

## Indications for use
The Cutera Er:YSGG Laser Handpiece 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.

Source page: https://510kreport.com/device/K063867
Methodology: https://510kreport.com/methodology