Company ยท US
Candela Laser Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1996. Name variants (Inc, Corp, punctuation) are merged.
43510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 28 |
| GEH | Unit, Cryosurgical, Accessories | 3 |
| ODF | Mini Endoscope, Gastroenterology-Urology | 3 |
| DQY | Catheter, Percutaneous | 2 |
| FFK | Lithotriptor, Electro-Hydraulic | 2 |
| HQF | Laser, Ophthalmic | 2 |
| FBX | Sound, Urethral, Metal Or Plastic | 1 |
| FDE | Laparoscopy Kit | 1 |
| FEB | Accessories, Cleaning, For Endoscope | 1 |
| FFL | Dislodger, Stone, Basket, Ureteral, Metal | 1 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| GXE | Leukotome | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 |
| IMD | Pack, Hot Or Cold, Disposable | 1 |
| LNK | Laser For Gastro-Urology Use | 1 |
| NWU | Endoscope Introducer Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 15, 1996 | K951033 | ANDELA DYNAMIC COOLING DEVICE Candela Laser Corp. | IMD |
| Jun 14, 1996 | K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS Candela Laser Corp. | GEX |
| Apr 3, 1996 | K955011 | CANDELA HCS 2000 URETHERAL WARMER CATHETER Candela Laser Corp. | GEH |
| Feb 5, 1996 | K954872 | CANDELA CRYO-PROBE HOLDER Candela Laser Corp. | GEH |
| Feb 2, 1996 | K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE Candela Laser Corp. | GEX |
| Oct 24, 1995 | K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM Candela Laser Corp. | GEX |
| Oct 18, 1995 | K953294 | CANDELA CRYOSYSTEM CS-5 Candela Laser Corp. | GEH |
| May 26, 1995 | K950831 | ALEXLAZR Candela Laser Corp. | GEX |
| Mar 24, 1995 | K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER Candela Laser Corp. | GEX |
| Mar 10, 1995 | K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE Candela Laser Corp. | GEX |
| Mar 9, 1995 | K943292 | CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS Candela Laser Corp. | GEX |
| Mar 6, 1995 | K950633 | CANDELA URETHRAL/BLADDER SOUND Candela Laser Corp. | FBX |
| Mar 1, 1995 | K950635 | CANDEKA DUKATIR SETS Candela Laser Corp. | DQY |
| Mar 1, 1995 | K950634 | CANDELA SHEATH SETS Candela Laser Corp. | DQY |
| Dec 8, 1994 | K945587 | CANDELA ELLIPTICAL SPOT HANDPIECE Candela Laser Corp. | GEX |
| Dec 7, 1994 | K940173 | CANDELA Q-SWITCHED ALEXANDRITE LASER Candela Laser Corp. | GEX |
| Nov 7, 1994 | K921995 | CANDELA H:ERB LASER Candela Laser Corp. | GEX |
| Sep 30, 1994 | K944090 | CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER Candela Laser Corp. | GEX |
| Sep 1, 1994 | K934811 | PLTL-1 & PLDL-1 510NM PULSED DYE LASERS Candela Laser Corp. | GEX |
| Jul 25, 1994 | K942152 | CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND;YAG LASER SY Candela Laser Corp. | GEX |
| Jun 17, 1994 | K941230 | MINI-UB ENDOSCOPES Candela Laser Corp. | ODF |
| Apr 29, 1994 | K934706 | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR Candela Laser Corp. | GEX |
| Mar 15, 1994 | K931762 | CANDELA SPTL PULSED DYE LASERS Candela Laser Corp. | GEX |
| Feb 10, 1994 | K933268 | CANDELA GUIDEWIRE Candela Laser Corp. | NWU |
| Feb 9, 1994 | K933016 | CANDELA PLTL-1 LASER SYSTEM Candela Laser Corp. | GEX |
| Oct 5, 1993 | K932930 | CANDELA MINIBRUSH Candela Laser Corp. | FEB |
| Jan 15, 1993 | K924158 | CANDELA LASSER SYSTEMS MODIFIED Candela Laser Corp. | GEX |
| Jun 5, 1992 | K920062 | CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS. Candela Laser Corp. | GEX |
| Jan 23, 1992 | K913314 | CANDELA RETINAL CAMERA Candela Laser Corp. | HKI |
| Aug 16, 1991 | K912443 | CANDELA INTRODUCER SHEATH SYSTEM Candela Laser Corp. | FDE |
| Apr 12, 1991 | K910732 | CANDELA MINI-UB ENDOSCOPE Candela Laser Corp. | ODF |
| Mar 4, 1991 | K910612 | CANDELA DIODE TRABECULOPLASTY LASER DTL Candela Laser Corp. | HQF |
| Oct 3, 1990 | K900858 | CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES Candela Laser Corp. | GEX |
| Jul 13, 1990 | K901723 | MDL-2000 LASERTRIPTER Candela Laser Corp. | LNK |
| May 11, 1990 | K900904 | CANDELA DIRECTABLE BILIARY CATHETER SYSTEM Candela Laser Corp. | FGE |
| Aug 2, 1989 | K893630 | CANDELA UPC LASER PHOTOCOAGULATOR Candela Laser Corp. | HQF |
| Jun 15, 1989 | K892516 | CANDELA PLDL-1 PULSED DYE LASER Candela Laser Corp. | GEX |
| Jun 1, 1989 | K885255 | MDL-1 LASERTRIPTER(TM) Candela Laser Corp. | FFK |
| Feb 9, 1989 | K884738 | CANDELA STONE BASKETS Candela Laser Corp. | FFL |
| Dec 28, 1988 | K884153 | CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE Candela Laser Corp. | FGB |
| Jul 5, 1988 | K882243 | SPTL-1 PULSED DYE LASER Candela Laser Corp. | GEX |
| Jun 17, 1988 | K880503 | MDL-1 LASERTRIPTER Candela Laser Corp. | FFK |
| Feb 19, 1988 | K874858 | LASERTRIPTER MINISCOPE Candela Laser Corp. | ODF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display Terminated |
GEX | None listed |
| Feb 15, 2007 | Candela Laser Corporation Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display Terminated |
GEX | K050673 |
| May 4, 2006 | Candela Laser Corporation Candela Laser VBeam Perfecta, a Pulsed Dye Laser used for General Surgery, Dermatology, Gynecology, Podiatry.
Model Number: 9914-00-0300 Terminated |
GXE | K050673 K051359 |
| Jan 1, 2004 | Candela Laser Corporation Candela Smoothbeam Laser System
Model Numbers: 9914-00-0820
9914-06-0820
9914-07-0820
9914-08-0820
Terminated |
GEX | K013825 K022884 +2 |