# Syneron Candela Corporation

- Location (FDA's records): Wayland, MA
- FDA decisions: 7 (2016–2018): 7 510(k) clearances
- Names in FDA's records: Syneron Candela Corporation (5); Syneron-Candela (1); Syneron-Candela Corp (1)
- Product codes: GEX (6), PBX (1)
- 510(k) review time since 2016: median 91 days, against 90 for FDA's reviews in the same codes and years (3 of 7 faster)
- Predicates its devices cite: 37 (6 its own); citations of its devices by later devices: 15 (6 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cynosure, Inc.: 17 (https://510kreport.com/company/cynosure)
- Candela Corp.: 5 (https://510kreport.com/company/candela)
- Candela Corpation: 4 (https://510kreport.com/company/candela-corpation)
- Primaeva Medical, Inc.: 2 (https://510kreport.com/company/primaeva-medical)
- Viora, Ltd.: 1 (https://510kreport.com/company/viora)
- Cutera, Inc.: 1 (https://510kreport.com/company/cutera)
- Syneron Medical, Ltd.: 1 (https://510kreport.com/company/syneron-medical)

## Firms that cite its devices most
- Cutera, Inc.: 2 (https://510kreport.com/company/cutera)
- Candela Corp.: 2 (https://510kreport.com/company/candela)
- Laseroptek Co., Ltd.: 2 (https://510kreport.com/company/laseroptek)
- Wontech Co., Ltd.: 1 (https://510kreport.com/company/wontech)
- Rhein Laser Technologies Co., Ltd.: 1 (https://510kreport.com/company/rhein-laser-technologies)
- Rohrer Aesthetics, LLC: 1 (https://510kreport.com/company/rohrer-aesthetics)

## Its most-cited devices
- K170597: PicoWay Laser System (2017), cited by 6
- K153527: PicoWay Laser System (2016), cited by 5
- K160607: PicoWay Laser System (2016), cited by 2
- K180593: Vbeam Prima Laser System (2018), cited by 1
- K162454: PicoWay Laser System (2017), cited by 1

## Recent decisions
- K181523: Syneron CO2RE System (Jul 11, 2018)
- K180593: Vbeam Prima Laser System (Jun 5, 2018)
- K170597: PicoWay Laser System (May 25, 2017)
- K162454: PicoWay Laser System (Feb 1, 2017)
- K161043: Profound System (Sep 12, 2016)
- K160607: PicoWay Laser System (Jul 5, 2016)
- K153527: PicoWay Laser System (Mar 2, 2016)

Source page: https://510kreport.com/company/syneron-candela