Company ยท US
Candela Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2024. Name variants (Inc, Corp, punctuation) are merged.
56510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 2024 | K240070 | Profound Matrix Candela Corporation | GEI |
| Jun 1, 2023 | K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) Candela Corporation | GEX |
| Oct 13, 2022 | K220853 | PicoWay Laser System Candela Corporation | GEX |
| Dec 20, 2021 | K212492 | Frax 1940 for Nordlys and Frax Pro Candela Corporation | GEX |
| Dec 16, 2021 | K211217 | Profound Matrix Candela Corporation | GEI |
| May 26, 2020 | K201111 | GentleMax Pro Plus Candela Corporation | GEX |
| Sep 16, 2019 | K191685 | PicoWay Laser System Candela Corporation | GEX |
| Feb 1, 2019 | K183452 | Vbeam Prima Laser System Candela Corp. | GEX |
| Apr 16, 2015 | K150326 | PicoWay Laser System Candela Corporation | GEX |
| Nov 7, 2014 | K140732 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS Candela Corp. | GEX |
| May 9, 2014 | K140122 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEM Candela Corp. | GEX |
| Dec 26, 2013 | K133283 | CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS Candela Corp. | GEX |
| Oct 5, 2011 | K112715 | CANDELA GENTLEMAX FAMILY OF LASERS Candela Corp. | GEX |
| Jul 18, 2011 | K111144 | CANDELA GENTLELASE FAMILY OF LASERS Candela Corp. | GEX |
| Jun 17, 2008 | K081324 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS Candela Corp. | GEX |
| Apr 3, 2008 | K073534 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS Candela Corp. | GEX |
| Aug 15, 2007 | K071469 | INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM Candela Corp. | GEX |
| Feb 5, 2007 | K063800 | CANDELA FLUORESCENT PULSED LIGHT SYSTEM Candela Corp. | GEX |
| Dec 27, 2006 | K063074 | CANDELA 3630 LASER SYSTEM Candela Corp. | GEX |
| Dec 20, 2006 | K063073 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS Candela Corp. | GEX |
| Dec 20, 2006 | K063072 | CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES Candela Corp. | GEX |
| Jul 13, 2005 | K051359 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY Candela Corp. | GEX |
| Jun 13, 2005 | K050673 | CANDELA FAMILY OF PULSE DYE LASER SYSTEMS Candela Corp. | GEX |
| Feb 9, 2005 | K043251 | CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B Candela Corp. | GEX |
| Nov 22, 2004 | K041242 | CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. | GEX |
| Jan 16, 2004 | K033461 | CANDELA VBEAM PULSE DYE LASER SYSTEM Candela Corp. | GEX |
| Jan 16, 2004 | K033331 | CANDELA CBEAM PULSE DYE LASER SYSTEM Candela Corp. | GEX |
| Dec 3, 2003 | K030834 | CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. | GEX |
| Oct 30, 2003 | K033172 | CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS Candela Corp. | GEX |
| Sep 16, 2003 | K030846 | CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. | GEX |
| Mar 31, 2003 | K024371 | CANDELA GENTLE LASE FAMILY OF LASER SYSTEM Candela Corp. | GEX |
| Mar 21, 2003 | K024260 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS Candela Corp. | GEX |
| Mar 13, 2003 | K022923 | CANDELA GENTLE YAG LASER SYSTEM Candela Corp. | GEX |
| Mar 12, 2003 | K024335 | CANDELA GENTLELASE FAMILY OF LASER SYSTEMS Candela Corp. | GEX |
| Jan 27, 2003 | K022951 | CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG Candela Corp. | GEX |
| Jan 22, 2003 | K022884 | CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. | GEX |
| Dec 20, 2002 | K023193 | CANDELA GENTLE YAG LASER SYSTEM Candela Corp. | GEX |
| Oct 4, 2002 | K014128 | CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. | GEX |
| Jul 2, 2002 | K021180 | CANDELA VBEAM PULSED DYE LASER SYSTEM Candela Corp. | GEX |
| Jun 21, 2002 | K020958 | CANDELA CBEAM PULSED DYE LASER SYSTEM Candela Corp. | GEX |
| Feb 15, 2002 | K013825 | CANDELA SMOOTHBEAM LASER SYSTEM Candela Corp. | GEX |
| Feb 11, 2002 | K013748 | CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) Candela Corp. | GEX |
| Oct 11, 2001 | K013043 | CANDELA CLEARBEAM PULSED DYE LASER Candela Corp. | GEX |
| Jul 9, 2001 | K011092 | CANDELA SPTL-1E PULSED DYE LASER Candela Corp. | GEX |
| Apr 11, 2001 | K010104 | CANDELA LONG PULSE ND:YAG Candela Corp. | GEX |
| Nov 3, 2000 | K002421 | CANDELA MID IR DIODE LASER SYSTEM Candela Corp. | GEX |
| Sep 19, 2000 | K001093 | CANDELA SPTL-1B PULSED DYE LASER Candela Corp. | GEX |
| Aug 18, 2000 | K001589 | CANDELA DYNAMIC COOLING DEVICE Candela Corp. | GEX |
| May 26, 2000 | K994260 | CANDELA GENTLELASE GL DERMATOLOGICAL LASER Candela Corp. | GEX |
| Jan 24, 2000 | K993671 | CANDELA SCLERO LONG PULSE DYE LASER Candela Corp. | GEX |
Newest 50 of 56.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 24, 2019 | Candela Corporation Canister HFC-134a /980g, ALUM, 15 pack
Product Number: 1600-00-0224
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
| Oct 24, 2019 | Candela Corporation Canister HFC-134a / 980g, ALUM
Product Number: 1600-00-0223
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
| Oct 24, 2019 | Candela Corporation Canister HFC-134a /1000g, ALUM, 15 pack
Product Number: 1600-00-0219
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
| Oct 24, 2019 | Candela Corporation Canister HFC-134a /1000g, ALUM
Product Number: 1600-00-0218
Revision .0C
Coolant canister for use with surgical laser. Terminated |
GEX | None listed |
| Nov 18, 2013 | Candela Corporation 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 Terminated |
GEX | K024260 K024335 +1 |