Candela Corporation
Marlborough, MA, US
Candela Corporation appears in FDA device records in Marlborough, MA. FDA records list 99 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 13 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Candela Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Candela Laser Corp.510(k), recall
510(k) clearance history
Showing 50 of 99FDA records hold 99 510(k) clearances for Candela Corporation between 1986 and 2024. The busiest year on record is 1994, with 11. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 2 |
| 1988 | 4 |
| 1989 | 4 |
| 1990 | 3 |
| 1991 | 3 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 11 |
| 1995 | 9 |
| 1996 | 5 |
| 1997 | 1 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 5 |
| 2001 | 3 |
| 2002 | 6 |
| 2003 | 9 |
| 2004 | 3 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 2 |
| 2011 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240070 | Profound Matrix | GEI | Substantially Equivalent | |
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | GEX | Substantially Equivalent | |
| K220853 | PicoWay Laser System | GEX | Substantially Equivalent | |
| K212492 | Frax 1940 for Nordlys and Frax Pro | GEX | Substantially Equivalent | |
| K211217 | Profound Matrix | GEI | Substantially Equivalent | |
| K201111 | GentleMax Pro Plus | GEX | Substantially Equivalent | |
| K191685 | PicoWay Laser System | GEX | Substantially Equivalent | |
| K183452 | Vbeam Prima Laser System | GEX | Substantially Equivalent | |
| K150326 | PicoWay Laser System | GEX | Substantially Equivalent | |
| K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | GEX | Substantially Equivalent | |
| K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM | GEX | Substantially Equivalent | |
| K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS | GEX | Substantially Equivalent | |
| K112715 | CANDELA GENTLEMAX FAMILY OF LASERS | GEX | Substantially Equivalent | |
| K111144 | CANDELA GENTLELASE FAMILY OF LASERS | GEX | Substantially Equivalent | |
| K081324 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS | GEX | Substantially Equivalent | |
| K073534 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | GEX | Substantially Equivalent | |
| K071469 | INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM | GEX | Substantially Equivalent | |
| K063800 | CANDELA FLUORESCENT PULSED LIGHT SYSTEM | GEX | Substantially Equivalent | |
| K063074 | CANDELA 3630 LASER SYSTEM | GEX | Substantially Equivalent | |
| K063073 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS | GEX | Substantially Equivalent | |
| K063072 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES | GEX | Substantially Equivalent | |
| K051359 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY | GEX | Substantially Equivalent | |
| K050673 | CANDELA FAMILY OF PULSE DYE LASER SYSTEMS | GEX | Substantially Equivalent | |
| K043251 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B | GEX | Substantially Equivalent | |
| K041242 | CANDELA SMOOTHBEAM LASER SYSTEM | GEX | Substantially Equivalent | |
| K033461 | CANDELA VBEAM PULSE DYE LASER SYSTEM | GEX | Substantially Equivalent | |
| K033331 | CANDELA CBEAM PULSE DYE LASER SYSTEM | GEX | Substantially Equivalent | |
| K030834 | CANDELA SMOOTHBEAM LASER SYSTEM | GEX | Substantially Equivalent | |
| K033172 | CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS | GEX | Substantially Equivalent | |
| K030846 | CANDELA SMOOTHBEAM LASER SYSTEM | GEX | Substantially Equivalent | |
| K024371 | CANDELA GENTLE LASE FAMILY OF LASER SYSTEM | GEX | Substantially Equivalent | |
| K024260 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | GEX | Substantially Equivalent | |
| K022923 | CANDELA GENTLE YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K024335 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS | GEX | Substantially Equivalent | |
| K022951 | CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG | GEX | Substantially Equivalent | |
| K022884 | CANDELA SMOOTHBEAM LASER SYSTEM | GEX | Substantially Equivalent | |
| K023193 | CANDELA GENTLE YAG LASER SYSTEM | GEX | Substantially Equivalent | |
| K014128 | CANDELA SMOOTHBEAM LASER SYSTEM | GEX | Substantially Equivalent | |
| K021180 | CANDELA VBEAM PULSED DYE LASER SYSTEM | GEX | Substantially Equivalent | |
| K020958 | CANDELA CBEAM PULSED DYE LASER SYSTEM | GEX | Substantially Equivalent | |
| K013825 | CANDELA SMOOTHBEAM LASER SYSTEM | GEX | Substantially Equivalent | |
| K013748 | CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) | GEX | Substantially Equivalent | |
| K013043 | CANDELA CLEARBEAM PULSED DYE LASER | GEX | Substantially Equivalent | |
| K011092 | CANDELA SPTL-1E PULSED DYE LASER | GEX | Substantially Equivalent | |
| K010104 | CANDELA LONG PULSE ND:YAG | GEX | Substantially Equivalent | |
| K002421 | CANDELA MID IR DIODE LASER SYSTEM | GEX | Substantially Equivalent | |
| K001093 | CANDELA SPTL-1B PULSED DYE LASER | GEX | Substantially Equivalent | |
| K001589 | CANDELA DYNAMIC COOLING DEVICE | GEX | Substantially Equivalent | |
| K994260 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER | GEX | Substantially Equivalent | |
| K993671 | CANDELA SCLERO LONG PULSE DYE LASER | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016496662 | 3016496662 | Candela Corporation | 251 Locke Drive, Marlborough, MA 01752 US | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEBAccessories, Cleaning, For Endoscope
- GFEBrush, Dermabrasion, Powered
- HKICamera, Ophthalmic, Ac-Powered
- DQYCatheter, Percutaneous
- FFLDislodger, Stone, Basket, Ureteral, Metal
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- NWUEndoscope Introducer Kit
- OLIFat Reducing Low Level Laser
- ILYLamp, Infrared, Therapeutic Heating
- FDELaparoscopy Kit
- LNKLaser For Gastro-Urology Use
- HQFLaser, Ophthalmic
- PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
- OHSLight Based Over The Counter Wrinkle Reduction
- FFKLithotriptor, Electro-Hydraulic
- NUVMassager, Vacuum, Light Induced Heating
- PBXMassager, Vacuum, Radio Frequency Induced Heat
- ODFMini Endoscope, Gastroenterology-Urology
- OLPOver-The-Counter Powered Light Based Laser For Acne
- IMDPack, Hot Or Cold, Disposable
- GEXPowered Laser Surgical Instrument
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
- FBXSound, Urethral, Metal Or Plastic
- FGEStents, Drains And Dilators For The Biliary Ducts
- GEHUnit, Cryosurgical, Accessories
- FGBUreteroscope And Accessories, Flexible/Rigid
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0209-2020 | Canister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant canister for use with surgical laser. | 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 | Class II | Terminated | |
| Z-0208-2020 | Canister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant canister for use with surgical laser. | 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 | Class II | Terminated | |
| Z-0207-2020 | Canister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C Coolant canister for use with surgical laser. | 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 | Class II | Terminated | |
| Z-0206-2020 | Canister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant canister for use with surgical laser. | 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 | Class II | Terminated | |
| 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 | Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause injury. | Class II | Terminated | |
| Z-0513-2007 | Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display | Internal component may overheat causing the possibility of risk of fire or smoke | Terminated | ||
| Z-0512-2007 | Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display | Internal component may overheat causing the possibility of risk of fire or smoke | Terminated | ||
| Z-0511-2007 | Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display | Internal component may overheat causing the possibility of risk of fire or smoke | Terminated | ||
| Z-0510-2007 | Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display | Internal component may overheat causing the possibility of risk of fire or smoke | Terminated | ||
| Z-0509-2007 | Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display | Internal component may overheat causing the possibility of risk of fire or smoke | Terminated | ||
| Z-0508-2007 | Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display | Internal component may overheat causing the possibility of risk of fire or smoke | Terminated | ||
| Z-0842-06 | Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry. Model Number: 9914-00-0300 | Handle fires even when the finger is off the switch | Terminated | ||
| Z-0291-04 | Candela Smoothbeam Laser System Model Numbers: 9914-00-0820 9914-06-0820 9914-07-0820 9914-08-0820 9914-10-0820 Units are the same except for color | Laser may pulse and not dispense cryogen resulting in patient injury | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain