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

43 devices

26-43 of 43

Cleared Oct 05, 1993

CANDELA MINIBRUSH

General Hospital · 112d

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 Jan 23, 1992

CANDELA RETINAL CAMERA

Ophthalmic · 182d

Cleared Aug 16, 1991

CANDELA INTRODUCER SHEATH SYSTEM

Gastroenterology & Urology · 74d

Cleared Apr 12, 1991

CANDELA MINI-UB ENDOSCOPE

Gastroenterology & Urology · 50d

Cleared Mar 04, 1991

CANDELA DIODE TRABECULOPLASTY LASER DTL

Ophthalmic · 20d

Cleared Oct 03, 1990

CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES

General & Plastic Surgery · 222d

Cleared Jul 13, 1990

MDL-2000 LASERTRIPTER

Gastroenterology & Urology · 88d

Cleared May 11, 1990

CANDELA DIRECTABLE BILIARY CATHETER SYSTEM

Gastroenterology & Urology · 73d

Cleared Aug 02, 1989

CANDELA UPC LASER PHOTOCOAGULATOR

Ophthalmic · 83d

Cleared Jun 15, 1989

CANDELA PLDL-1 PULSED DYE LASER

General & Plastic Surgery · 65d

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 Jul 05, 1988

SPTL-1 PULSED DYE LASER

General & Plastic Surgery · 35d

Cleared Jun 17, 1988

MDL-1 LASERTRIPTER

Gastroenterology & Urology · 130d

Cleared Feb 19, 1988

LASERTRIPTER MINISCOPE

Gastroenterology & Urology · 86d