Candela Corporation
Candela Corporation holds FDA 510(k) medical device clearances, first cleared 2015, most recent 2024, with 5 FDA device recalls on record.
Top product codes for Candela Corporation
FDA recalls by Candela Corporation
- Z-0209-2020 — Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser.
- Z-0208-2020 — Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser.
- Z-0207-2020 — Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser.
- Z-0206-2020 — Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser.
- Z-0348-2014 — Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model number: 9914-00-9015. and Candela Laser GentleLase Pro LE, Model number: 9914-00-9040
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Candela Corporation
Data sourced from openFDA. This site is unofficial and independent of the FDA.