Candela Laser Corp. - FDA 510(k) Cleared Devices
43
Total
43
Cleared
0
Denied
FDA 510(k) Regulatory Record - Candela Laser Corp. Gastroenterology & Urology ✕
12 devices
Cleared
Mar 06, 1995
CANDELA URETHRAL/BLADDER SOUND
Gastroenterology & Urology
21d
Cleared
Jun 17, 1994
MINI-UB ENDOSCOPES
Gastroenterology & Urology
94d
Cleared
Feb 10, 1994
CANDELA GUIDEWIRE
Gastroenterology & Urology
219d
Cleared
Aug 16, 1991
CANDELA INTRODUCER SHEATH SYSTEM
Gastroenterology & Urology
74d
Cleared
Apr 12, 1991
CANDELA MINI-UB ENDOSCOPE
Gastroenterology & Urology
50d
Cleared
Jul 13, 1990
MDL-2000 LASERTRIPTER
Gastroenterology & Urology
88d
Cleared
May 11, 1990
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
Gastroenterology & Urology
73d
Cleared
Jun 01, 1989
MDL-1 LASERTRIPTER(TM)
Gastroenterology & Urology
160d
Cleared
Feb 09, 1989
CANDELA STONE BASKETS
Gastroenterology & Urology
87d
Cleared
Dec 28, 1988
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
Gastroenterology & Urology
89d
Cleared
Jun 17, 1988
MDL-1 LASERTRIPTER
Gastroenterology & Urology
130d
Cleared
Feb 19, 1988
LASERTRIPTER MINISCOPE
Gastroenterology & Urology
86d