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Candela Corporation

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
8
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0207-2020Class IICanister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canisSeptember 10, 2019
Z-0206-2020Class IICanister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for uSeptember 10, 2019
Z-0209-2020Class IICanister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canisteSeptember 10, 2019
Z-0208-2020Class IICanister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for uSeptember 10, 2019
Z-0348-2014Class IICandela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model numbeNovember 6, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K240070Profound MatrixJuly 1, 2024
K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)June 1, 2023
K220853PicoWay Laser SystemOctober 13, 2022
K212492Frax 1940 for Nordlys and Frax ProDecember 20, 2021
K211217Profound MatrixDecember 16, 2021
K201111GentleMax Pro PlusMay 26, 2020
K191685PicoWay Laser SystemSeptember 16, 2019
K150326PicoWay Laser SystemApril 16, 2015