# K102954: Cutera Qswitch Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cutera, Inc.
- Decided: Jun 22, 2011 after 260 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: 16 generations back to K943450 (1995). 249 ancestors in all.
49 later devices descend from it; 2 cite it directly.
0 of 299 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083899: Revlite Q-Switched ND:Yag Laser System, Hoya Conbio, Inc. (2009) Summary page 1.

## Most influential descendants
- K140727: Cutera Picosecond Laser System (2014), 47 descendants of its own
- K153527: PicoWay Laser System (2016), 41 descendants of its own
- K160607: PicoWay Laser System (2016), 34 descendants of its own
- K162454: PicoWay Laser System (2017), 33 descendants of its own
- K170597: PicoWay Laser System (2017), 32 descendants of its own

## Indications for use
Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Indications for Use: 1064 nm wavelength * Tattoo Removal (dark ink: blue and black) * Nevus of Ota * Removal or lightening of hair with or without adjuvant preparation. * Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions, such as, but not limited to: striae and scars * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar 532 nm wavelength * Tattoo removal (light ink: red, sky blue, green) * Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi * Epiderrmal Pigmented lesions including but not limited to: cafe-au-Iait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus * Skin Resurfacing for Acne Scars and Wrinkles * Benign cutaneous lesions, such as, but not limited to: striae and scars * Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar

Source page: https://510kreport.com/device/K102954
Methodology: https://510kreport.com/methodology