Candela Laser Corp. - FDA 510(k) Cleared Devices
43
Total
43
Cleared
0
Denied
FDA 510(k) Regulatory Record - Candela Laser Corp. General & Plastic Surgery ✕
24 devices
Cleared
Jun 14, 1996
CANDELA Q-SWITCHED ALEXANDRITE LASERS
General & Plastic Surgery
185d
Cleared
Apr 03, 1996
CANDELA HCS 2000 URETHERAL WARMER CATHETER
General & Plastic Surgery
154d
Cleared
Feb 05, 1996
CANDELA CRYO-PROBE HOLDER
General & Plastic Surgery
104d
Cleared
Feb 02, 1996
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
General & Plastic Surgery
98d
Cleared
Oct 24, 1995
CANDELA MODEL PLTL-1 LASER SYSTEM
General & Plastic Surgery
96d
Cleared
Oct 18, 1995
CANDELA CRYOSYSTEM CS-5
General & Plastic Surgery
96d
Cleared
May 26, 1995
ALEXLAZR
General & Plastic Surgery
91d
Cleared
Mar 24, 1995
CANDELA RUBY LAZE Q-SWITCHED RUBY LASER
General & Plastic Surgery
93d
Cleared
Mar 10, 1995
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE
General & Plastic Surgery
25d
Cleared
Mar 09, 1995
CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS
General & Plastic Surgery
244d
Cleared
Dec 08, 1994
CANDELA ELLIPTICAL SPOT HANDPIECE
General & Plastic Surgery
24d
Cleared
Dec 07, 1994
CANDELA Q-SWITCHED ALEXANDRITE LASER
General & Plastic Surgery
330d
Cleared
Nov 07, 1994
CANDELA H:ERB LASER
General & Plastic Surgery
923d
Cleared
Sep 30, 1994
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER
General & Plastic Surgery
39d
Cleared
Sep 01, 1994
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS
General & Plastic Surgery
329d
Cleared
Jul 25, 1994
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND
General & Plastic Surgery
83d
Cleared
Apr 29, 1994
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR
General & Plastic Surgery
211d
Cleared
Mar 15, 1994
CANDELA SPTL PULSED DYE LASERS
General & Plastic Surgery
341d
Cleared
Feb 09, 1994
CANDELA PLTL-1 LASER SYSTEM
General & Plastic Surgery
233d
Cleared
Jan 15, 1993
CANDELA LASSER SYSTEMS MODIFIED
General & Plastic Surgery
150d
Cleared
Jun 05, 1992
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.
General & Plastic Surgery
150d
Cleared
Oct 03, 1990
CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
General & Plastic Surgery
222d
Cleared
Jun 15, 1989
CANDELA PLDL-1 PULSED DYE LASER
General & Plastic Surgery
65d
Cleared
Jul 05, 1988
SPTL-1 PULSED DYE LASER
General & Plastic Surgery
35d