Medical Device Manufacturer · US , Wayland , MA

Candela Laser Corp. - FDA 510(k) Cleared Devices

43 submissions · 43 cleared · Since 1988
43
Total
43
Cleared
0
Denied

FDA 510(k) Regulatory Record - Candela Laser Corp. General & Plastic Surgery

24 devices
1-24 of 24
Cleared Jun 14, 1996
CANDELA Q-SWITCHED ALEXANDRITE LASERS
K955662 · GEX
General & Plastic Surgery · 185d
Cleared Apr 03, 1996
CANDELA HCS 2000 URETHERAL WARMER CATHETER
K955011 · GEH
General & Plastic Surgery · 154d
Cleared Feb 05, 1996
CANDELA CRYO-PROBE HOLDER
K954872 · GEH
General & Plastic Surgery · 104d
Cleared Feb 02, 1996
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
K954934 · GEX
General & Plastic Surgery · 98d
Cleared Oct 24, 1995
CANDELA MODEL PLTL-1 LASER SYSTEM
K953412 · GEX
General & Plastic Surgery · 96d
Cleared Oct 18, 1995
CANDELA CRYOSYSTEM CS-5
K953294 · GEH
General & Plastic Surgery · 96d
Cleared May 26, 1995
ALEXLAZR
K950831 · GEX
General & Plastic Surgery · 91d
Cleared Mar 24, 1995
CANDELA RUBY LAZE Q-SWITCHED RUBY LASER
K946386 · GEX
General & Plastic Surgery · 93d
Cleared Mar 10, 1995
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE
K950661 · GEX
General & Plastic Surgery · 25d
Cleared Mar 09, 1995
CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS
K943292 · GEX
General & Plastic Surgery · 244d
Cleared Dec 08, 1994
CANDELA ELLIPTICAL SPOT HANDPIECE
K945587 · GEX
General & Plastic Surgery · 24d
Cleared Dec 07, 1994
CANDELA Q-SWITCHED ALEXANDRITE LASER
K940173 · GEX
General & Plastic Surgery · 330d
Cleared Nov 07, 1994
CANDELA H:ERB LASER
K921995 · GEX
General & Plastic Surgery · 923d
Cleared Sep 30, 1994
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER
K944090 · GEX
General & Plastic Surgery · 39d
Cleared Sep 01, 1994
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS
K934811 · GEX
General & Plastic Surgery · 329d
Cleared Jul 25, 1994
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND
K942152 · GEX
General & Plastic Surgery · 83d
Cleared Apr 29, 1994
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR
K934706 · GEX
General & Plastic Surgery · 211d
Cleared Mar 15, 1994
CANDELA SPTL PULSED DYE LASERS
K931762 · GEX
General & Plastic Surgery · 341d
Cleared Feb 09, 1994
CANDELA PLTL-1 LASER SYSTEM
K933016 · GEX
General & Plastic Surgery · 233d
Cleared Jan 15, 1993
CANDELA LASSER SYSTEMS MODIFIED
K924158 · GEX
General & Plastic Surgery · 150d
Cleared Jun 05, 1992
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.
K920062 · GEX
General & Plastic Surgery · 150d
Cleared Oct 03, 1990
CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
K900858 · GEX
General & Plastic Surgery · 222d
Cleared Jun 15, 1989
CANDELA PLDL-1 PULSED DYE LASER
K892516 · GEX
General & Plastic Surgery · 65d
Cleared Jul 05, 1988
SPTL-1 PULSED DYE LASER
K882243 · GEX
General & Plastic Surgery · 35d
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