# Cutera, Inc.

- Location (FDA's records): Brisbane, CA
- FDA decisions: 31 (2004–2025): 31 510(k) clearances
- Product codes: GEX (20), PBX (5), NUV (2), GEI (2), PDZ (1), ILY (1)
- 510(k) review time since 2016: median 79 days, against 102 for FDA's reviews in the same codes and years (11 of 14 faster)
- Predicates its devices cite: 66 (20 its own); citations of its devices by later devices: 61 (20 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cynosure, Inc.: 8 (https://510kreport.com/company/cynosure)
- Altus Medical, Inc.: 6 (https://510kreport.com/company/altus-medical)
- Syneron Medical, Ltd.: 6 (https://510kreport.com/company/syneron-medical)
- Sciton, Inc: 3 (https://510kreport.com/company/sciton)
- Quanta System Spa: 3 (https://510kreport.com/company/quanta-system)
- Syneron Candela Corporation: 2 (https://510kreport.com/company/syneron-candela)
- Medical Laser Technologies, Ltd.: 2 (https://510kreport.com/company/medical-laser-technologies)
- Candela Corp.: 2 (https://510kreport.com/company/candela)

## Firms that cite its devices most
- Alma Lasers, Inc.: 6 (https://510kreport.com/company/alma-lasers)
- Sciton, Inc: 3 (https://510kreport.com/company/sciton)
- Lutronic Corporation: 3 (https://510kreport.com/company/lutronic)
- Wontech Co., Ltd.: 3 (https://510kreport.com/company/wontech)
- Sharplight Technologies, Ltd.: 2 (https://510kreport.com/company/sharplight-technologies)
- Fotona D.D.: 2 (https://510kreport.com/company/fotona-dd)
- Biolase, Inc.: 1 (https://510kreport.com/company/biolase)
- Viora, Ltd.: 1 (https://510kreport.com/company/viora)

## Its most-cited devices
- K103626: Cutera Genesisplus Laser System (2011), cited by 7
- K153671: Family of CoolGlide Aesthetic Lasers (2016), cited by 6
- K050047: Cutera Optional Pulsed Light Hand Piece Family (2005), cited by 5
- K133739: Trusculpt (2014), cited by 5
- K042165: Cutera Tabletop Aesthetic Product (2004), cited by 4
- K122493: Genesisplus (2013), cited by 3

## Recent decisions
- K251149: AviClear Laser System (Jul 11, 2025)
- K233237: xeo+ Family (Dec 15, 2023)
- K230660: AviClear Laser System (Jun 6, 2023)
- K223110: truSculpt iD (Nov 3, 2022)
- K221407: truSculpt iD (Jul 13, 2022)
- K213461: AviClear Laser System (Mar 24, 2022)
- K182997: enlighten III Laser System (Dec 12, 2018)
- K180709: truSculpt RF Device; truSculpt; truSculpt 3D (Jun 6, 2018)

Source page: https://510kreport.com/company/cutera