# Cynosure, Inc.

- Location (FDA's records): Wesford, MA
- FDA decisions: 107 (1992–2026): 107 510(k) clearances
- Names in FDA's records: Cynosure, Inc. (98); Cynosure, LLC (8); Cynosure (1)
- Product codes: GEX (84), PKT (6), GEI (5), ILY (4), OHS (2), OYW (2), ISA (1), PBX (1), GAT (1), FTC (1)
- 510(k) review time since 2016: median 88 days, against 95 for FDA's reviews in the same codes and years (8 of 14 faster)
- Predicates its devices cite: 69 (39 its own); citations of its devices by later devices: 197 (39 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Zeltiq Aesthetics, Inc.: 6 (https://510kreport.com/company/zeltiq-aesthetics)
- Zimmer Elektromedizin GmbH: 3 (https://510kreport.com/company/zimmer-elektromedizin)
- Palomar Medical Technologies, Inc.: 3 (https://510kreport.com/company/palomar-medical-technologies)
- Ellman International, Inc.: 3 (https://510kreport.com/company/ellman-international)
- Hoya Photonics, Inc.: 3 (https://510kreport.com/company/hoya-photonics)
- Valleylab, Inc.: 2 (https://510kreport.com/company/valleylab)
- El.En Electronic Engineering Spa: 1 (https://510kreport.com/company/el-en-electronic-engineering)
- Miramar Labs, Inc.: 1 (https://510kreport.com/company/miramar-labs)

## Firms that cite its devices most
- Syneron Candela Corporation: 17 (https://510kreport.com/company/syneron-candela)
- Candela Corp.: 13 (https://510kreport.com/company/candela)
- Cutera, Inc.: 8 (https://510kreport.com/company/cutera)
- Sciton, Inc: 6 (https://510kreport.com/company/sciton)
- Quanta System Spa: 5 (https://510kreport.com/company/quanta-system)
- Alma Lasers, Inc.: 5 (https://510kreport.com/company/alma-lasers)
- El.En Electronic Engineering Spa: 4 (https://510kreport.com/company/el-en-electronic-engineering)
- Wuhan Lotuxs Technology Co., Ltd.: 4 (https://510kreport.com/company/wuhan-lotuxs-technology)

## Its most-cited devices
- K034030: Apogee Elite (2004), cited by 14
- K121346: Picosure Workstation (2012), cited by 12
- K062321: Smartlipo ND:Yag Laser (2006), cited by 8
- K133254: Revlite Q-Switched ND:Yag Laser System (2014), cited by 8
- K992757: Cynosure Apogee-TKS Dermatological Laser (2000), cited by 8
- K971737: Cynosure Photogenica Lpir Dermatological Laser (1997), cited by 8

## Recent decisions
- K261570: Picosure Workstation (Jun 17, 2026)
- K240396: Elite iQ PRO (M122K1) (Mar 8, 2024)
- K230510: MyEllevate (Jul 6, 2023)
- K223292: TempSure System (Nov 23, 2022)
- K212891: TempSure System (Mar 18, 2022)
- K210226: PicoSure Workstation (Mar 30, 2021)
- K200241: TempSure System (Mar 25, 2020)
- K193426: Elite iQ (Mar 9, 2020)

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