# Candela Corp.

- Location (FDA's records): Wayland, MA
- FDA decisions: 56 (1986–2024): 56 510(k) clearances
- Names in FDA's records: Candela Corp. (48); Candela Corporation (8)
- Product codes: GEX (53), GEI (2), FFK (1)
- 510(k) review time since 2016: median 109 days, against 107 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 129 (65 its own); citations of its devices by later devices: 176 (65 its own)
- Recalls linked to its devices: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Cynosure, Inc.: 13 (https://510kreport.com/company/cynosure)
- Laserscope: 9 (https://510kreport.com/company/laserscope)
- Candela Laser Corp.: 9 (https://510kreport.com/company/candela-laser)
- Icn Photonics, Ltd.: 4 (https://510kreport.com/company/icn-photonics)
- Altus Medical, Inc.: 3 (https://510kreport.com/company/altus-medical)
- Syneron Candela Corporation: 2 (https://510kreport.com/company/syneron-candela)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Lutronic Corporation: 2 (https://510kreport.com/company/lutronic)

## Firms that cite its devices most
- Sciton, Inc: 11 (https://510kreport.com/company/sciton)
- Reliant Technologies, Inc.: 5 (https://510kreport.com/company/reliant-technologies)
- Syneron Candela Corporation: 5 (https://510kreport.com/company/syneron-candela)
- Altus Medical, Inc.: 5 (https://510kreport.com/company/altus-medical)
- Light Age, Inc.: 5 (https://510kreport.com/company/light-age)
- Lumenis, Inc.: 4 (https://510kreport.com/company/lumenis)
- Adept Medical Concepts: 4 (https://510kreport.com/company/adept-medical-concepts)
- Hoya Conbio, Inc.: 4 (https://510kreport.com/company/hoya-conbio)

## Its most-cited devices
- K994260: Candela Gentlelase GL Dermatological Laser (2000), cited by 11
- K033172: Candela Gentleyag Family of Laser Systems (2003), cited by 10
- K191685: PicoWay Laser System (2019), cited by 8
- K150326: PicoWay Laser System (2015), cited by 6
- K024371: Candela Gentle Lase Family of Laser System (2003), cited by 6
- K024260: Candela Gentlelase Family of Laser Systems (2003), cited by 6

## Recent decisions
- K240070: Profound Matrix (Jul 1, 2024)
- K230990: Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) (Jun 1, 2023)
- K220853: PicoWay Laser System (Oct 13, 2022)
- K212492: Frax 1940 for Nordlys and Frax Pro (Dec 20, 2021)
- K211217: Profound Matrix (Dec 16, 2021)
- K201111: GentleMax Pro Plus (May 26, 2020)
- K191685: PicoWay Laser System (Sep 16, 2019)
- K183452: Vbeam Prima Laser System (Feb 1, 2019)

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