Candela Corp.
FDA Regulatory Profile
Candela Corp. has 5 FDA recalls, 4 inspections, 56 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-0208-2020 · Class II · Sep 10, 2019
- Latest inspection
- Jan 24, 2023 · VAI
- Latest 510(k)
- Jul 1, 2024
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | Oct 23, 2026 | Not stated | Current |
|---|
| 510(k) clearances | 56 | Oct 4, 2026 | Not stated | Current |
|---|
| Inspections | 4 | Oct 26, 2026 | Not stated | Current |
|---|
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0208-2020 | Class II | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for… | Sep 10, 2019 |
| Z-0207-2020 | Class II | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant… | Sep 10, 2019 |
| Z-0206-2020 | Class II | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for… | Sep 10, 2019 |
| Z-0209-2020 | Class II | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant… | Sep 10, 2019 |
| Z-0348-2014 | Class II | Candela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use - Model… | Nov 6, 2013 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Jan 24, 2023 | Marlborough, MA | Devices | Voluntary Action Indicated (VAI) | 3016496662 |
| Feb 8, 2017 | Marlborough, MA | Devices | Voluntary Action Indicated (VAI) | 1218402 |
| Feb 21, 2014 | Marlborough, MA | Devices | Voluntary Action Indicated (VAI) | 1218402 |
| Oct 18, 2011 | Marlborough, MA | Devices | Voluntary Action Indicated (VAI) | 1218402 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| 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 |
| K150326 | PicoWay Laser System | Apr 16, 2015 |
| K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | Nov 7, 2014 |
| K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM | May 9, 2014 |
| K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS | Dec 26, 2013 |
| K112715 | CANDELA GENTLEMAX FAMILY OF LASERS | Oct 5, 2011 |
| K111144 | CANDELA GENTLELASE FAMILY OF LASERS | Jul 18, 2011 |
| K081324 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS | Jun 17, 2008 |
| K073534 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | Apr 3, 2008 |
| K071469 | INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM | Aug 15, 2007 |
| K063800 | CANDELA FLUORESCENT PULSED LIGHT SYSTEM | Feb 5, 2007 |
| K063074 | CANDELA 3630 LASER SYSTEM | Dec 27, 2006 |
| K063072 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE… | Dec 20, 2006 |