Candela Corporation
FDA Regulatory Profile
Candela Corporation appears in FDA public data with 5 recalls, 8 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0209-2020, Class II) was initiated on September 10, 2019. Its most recent 510(k) clearance was granted on July 1, 2024.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 8
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0209-2020 | Class II | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant caniste | September 10, 2019 |
| Z-0208-2020 | Class II | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for u | September 10, 2019 |
| Z-0207-2020 | Class II | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canis | September 10, 2019 |
| Z-0206-2020 | Class II | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for u | September 10, 2019 |
| Z-0348-2014 | Class II | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model numbe | November 6, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K240070 | Profound Matrix | July 1, 2024 |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | June 1, 2023 |
| K220853 | PicoWay Laser System | October 13, 2022 |
| K212492 | Frax 1940 for Nordlys and Frax Pro | December 20, 2021 |
| K211217 | Profound Matrix | December 16, 2021 |
| K201111 | GentleMax Pro Plus | May 26, 2020 |
| K191685 | PicoWay Laser System | September 16, 2019 |
| K150326 | PicoWay Laser System | April 16, 2015 |