# Candela Laser Corp.

- Location (FDA's records): Wayland, MA
- FDA decisions: 43 (1988–1996): 43 510(k) clearances
- Product codes: GEX (21), GEH (3), ODF (3), HQF (2), FFK (2), DQY (2), NWU (1), FGB (1), HKI (1), IMD (1), FFL (1), FDE (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 25 (0 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
- Cryomedical Sciences, Inc.: 1 (https://510kreport.com/company/cryomedical-sciences)

## Firms that cite its devices most
- Candela Corp.: 9 (https://510kreport.com/company/candela)
- Coherent Medical Group: 3 (https://510kreport.com/company/coherent-medical-group)
- Silver Creek, Inc.: 3 (https://510kreport.com/company/silver-creek)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Quantel Medical: 1 (https://510kreport.com/company/quantel-medical)
- Electro Medical Systems SA: 1 (https://510kreport.com/company/electro-medical-systems)
- Dofi Technologies, Inc.: 1 (https://510kreport.com/company/dofi-technologies)
- Optomed OY: 1 (https://510kreport.com/company/optomed)

## Its most-cited devices
- K951033: Andela Dynamic Cooling Device (1996), cited by 5
- K955662: Candela Q-Switched Alexandrite Lasers (1996), cited by 3
- K944090: Candela Alex Lazr Q-Switched Alexandrite Laser (1994), cited by 3
- K940173: Candela Q-Switched Alexandrite Laser (1994), cited by 2
- K954934: Candela SPTL Long Pulse/Tunable Pulsed Dye Lase (1996), cited by 2
- K950831: Alexlazr (1995), cited by 2

## Recent decisions
- K951033: Andela Dynamic Cooling Device (Aug 15, 1996)
- K955662: Candela Q-Switched Alexandrite Lasers (Jun 14, 1996)
- K955011: Candela HCS 2000 Uretheral Warmer Catheter (Apr 3, 1996)
- K954872: Candela Cryo-Probe Holder (Feb 5, 1996)
- K954934: Candela SPTL Long Pulse/Tunable Pulsed Dye Lase (Feb 2, 1996)
- K953412: Candela Model PLTL-1 Laser System (Oct 24, 1995)
- K953294: Candela Cryosystem CS-5 (Oct 18, 1995)
- K950831: Alexlazr (May 26, 1995)

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