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Sign in to claim this brandCandela Corporation
United States·US-MF-000022750
Last updated September 17, 2026
What Candela Corporation makes
Candela Corporation manufactures dermatological laser systems and accessories, including solid-state lasers, carbon dioxide lasers, and dye lasers for skin treatments. Their portfolio includes multi-modality devices for skin surface and body contouring, as well as handpieces for laser beam guidance and delivery. Examples include systems like the GentleMax Pro and Vbeam Perfecta, along with single-use cartridges and delivery assemblies for precise skin treatments.
The company’s devices are regulated as Class II, Class IIa, and Class IIb medical devices, with listings in the EU’s eudamed registry and the FDA’s 510(k) and UDI databases. Candela Corporation is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Candela Corporation manufacture?
Candela Corporation specializes in dermatological laser systems and accessories. Their portfolio includes dermatological laser beam guiding and producing handpieces, solid-state laser systems, dye lasers, and carbon dioxide lasers. They also produce multi-modality devices for skin surface and body contouring treatments, such as the GentleMax Pro and Vbeam Perfecta. These devices are designed for precise skin treatments and aesthetic procedures.
Where is Candela Corporation based?
Candela Corporation is headquartered in the United States. The company’s location in the US influences its regulatory compliance, particularly with FDA requirements for medical devices.
In which regulatory registries are Candela Corporation’s devices listed?
Candela Corporation’s devices are listed in multiple regulatory databases, including the EU’s eudamed registry and the FDA’s 510(k) premarket notification database as well as the FDA’s Unique Device Identifier (UDI) database. These listings reflect their compliance with EU and US medical device regulations, ensuring traceability and transparency in their product portfolio.
How are Candela Corporation’s devices classified under medical device regulations?
Candela Corporation’s devices fall under Class II, Class IIa, and Class IIb classifications. These classifications are determined by the level of risk associated with the device’s intended use. Class II devices typically require special controls beyond general controls to ensure safety and effectiveness, while Class IIa and IIb represent varying degrees of risk within this category. The specific classification depends on factors like the device’s purpose, potential risks, and the body’s interaction with it.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 251, Locke Drive, Marlborough, United States
- Website
- candelamedical.com
- —
- —
- [email protected]
- Phone
- +19253258206
- PRRC Contact
- Greg Wallender
- EUDAMED SRN
- US-MF-000022750
- FDA FEI Number
- 3016496662
- DUNS Number
- —
Catalogue (528)
Page 3 of 11| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Matrix Pro Cartridge box (pack of 7) | KT78161 | FDA UDI | Class II | Unknown |
| GentleYAG HR/VR Delivery System W/O DCD | 0800-00-1063 | FDA UDI | Class II | Unknown |
| Perfecta Delivery System, Refurbished | FIN100984 | FDA UDI | Class II | Active |
| SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III | AS87512 | FDA UDI | Class II | Active |
| Vbeam Delivery System Assembly, Japan | 0800-00-1095 | FDA UDI | Class II | Unknown |
| GentleYAG Pro-U | 9914-12-9020 | FDA UDI | Class II | Active |
| CO2RE System, Packaged (Japan) | FG70412JP | FDA UDI | Class II | Active |
| Fiber, Large Spot, Gc, Gmpp | 7123-CE-0635 | FDA UDI | Class II | Active |
| GentleLASE | 9914-11-0890 | FDA UDI | Class II | Unknown |
| GentleMax | 9914-00-0422 | FDA UDI | Class II | Unknown |
| SubQ applicator | FG71501 | FDA UDI | Class II | Active |
| Alex TriVantage | 9914-KK-2025 | FDA UDI | Class II | Active |
| Vbeam Prima Pro Laser System | 9914-00-9092 | FDA UDI | Class II | Active |
| GentleMax Pro Plus | 7123-00-0651 | FDA UDI | Class II | Unknown |
| GentleYAG | 9914-00-0961 | FDA UDI | Class II | Unknown |
| GentleMax | 9914-00-0401 | FDA UDI | Class II | Unknown |
| Vbeam | 9914-10-0723 | FDA UDI | Class II | Unknown |
| Alex TriVantage 755 Delivery System | 0800-00-1082 | FDA UDI | Class II | Unknown |
| Frax Pro | 9SYS7852-001-CNDL | FDA UDI | Class II | Active |
| GentleCool Pro Canister Cryogen (R134a / 980g / US) | FIN103320 | FDA UDI | Class II | Active |
| GentleYAG 3MM Delivery System W/O DCD | 7122-00-3630 | FDA UDI | Class II | Active |
| GentleYAG 12/15/18 RGD Delivery System W/DCD | 7122-00-3792 | FDA UDI | Class II | Active |
| Focal 44 Sublative iD (200 Pulses), 10 Pack | KT72962 | FDA UDI | Class II | Active |
| CO2RE system | FG70412 | FDA UDI | Class II | Active |
| GentleLASE | 9914-00-9040 | FDA UDI | Class II | Unknown |
| Fse Alex2 532 Hp Assy | 7122-57-9150 | FDA UDI | Class II | Active |
| Vbeam Platinum | 9914-00-0312 | FDA UDI | Class II | Active |
| Matrix Pro Applicator, Profound Matrix | FG71851 | FDA UDI | Class II | Active |
| GentleLase Pro Limited Edition | 9914-16-9040 | FDA UDI | Class II | Unknown |
| Vbeam 18MM Delivery System W/DCD | 7122-00-3313 | FDA UDI | Class II | Unknown |
| GentleMax Pro | 9914-15-9035 | FDA UDI | Class II | Active |
| GentleLASE | 9914-10-0720 | FDA UDI | Class II | Unknown |
| Vbeam Delivery System W/Fiber | 7122-00-3131 | FDA UDI | Class II | Active |
| GentleLase LE 10/12/15 RGD Delivery System | 7122-00-7551 | FDA UDI | Class II | Unknown |
| GentleLase 6/8/10MM RGD Delivery System W/DCD | 7122-00-3837 | FDA UDI | Class II | Active |
| Intima Sterile 2 Internal + 1 External HP, Accessories Kit | KT78011 | FDA UDI | Class II | Active |
| GentleYAG 6/8/10MM RGD Delivery System W/DCD | 7122-00-3836 | FDA UDI | Class II | Active |
| GentleLASE Limited Edition | 9914-11-0910 | FDA UDI | Class II | Unknown |
| Alex TriVantage | 9914-00-2011 | FDA UDI | Class II | Unknown |
| GentleLASE | 9914-00-2140 | FDA UDI | Class II | Unknown |
| GentleLase LE 12MM Delivery System W/DCD | 0800-00-1072 | FDA UDI | Class II | Unknown |
| MGL-LE 10/12/15MM RGD Fiber | 7122-00-7548 | FDA UDI | Class II | Unknown |
| GentleLASE Pro-U | 9914-15-9030 | FDA UDI | Class II | Active |
| Dermal Single- Use Cartridge 6-Pkg, Profound, | KT76653 | FDA UDI | Class II | Active |
| PRO Series Fiber Assembly | 7122-00-9419 | FDA UDI | Class II | Active |
| GentleYAG12MM Fiber Assembly | 7122-00-3122 | FDA UDI | Class II | Unknown |
| GentleLASE | 9914-12-0898 | FDA UDI | Class II | Unknown |
| Refurbished GentleMax Pro Plus | 9914-58-9036 | FDA UDI | Class II | Active |
| GentleMax Limited Edition | 9914-00-0331 | FDA UDI | Class II | Unknown |
| Vbeam Handpiece Assembly | 7122-00-0670 | FDA UDI | Class II | Unknown |
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Candela Corporation has five FDA recall records initiated between November 6, 2013, and September 10, 2019, all of which are marked as terminated. The reasons cited include potential separation of the canister neck bushing from the canister body during use in legacy devices with specific module types, and the possibility of unintended single pulse emissions from handpieces prior to trigger or footswitch activation.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 10, 2019 | Z-0209-2020 | — | terminated | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules |
| Sep 10, 2019 | Z-0206-2020 | — | terminated | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules |
| Sep 10, 2019 | Z-0207-2020 | — | terminated | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules |
| Sep 10, 2019 | Z-0208-2020 | — | terminated | The canister neck bushing may become loose and separate from the body of the canister during use. The issue occurs only when the canisters are used in Candela legacy devices that utilize screw-in or threaded interface type DCD modules |
| Nov 6, 2013 | Z-0348-2014 | — | terminated | Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. |