Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

43 results for "Candela Laser Corp."
25–43 of 43
Search insights Median review: 96d Cleared: 100% Top manufacturer: Candela Laser Corp. Lead specialty: General & Plastic Surgery
Cleared Feb 09, 1994
CANDELA PLTL-1 LASER SYSTEM
K933016 · GEX
Candela Laser Corp.
General & Plastic Surgery · 233d
Cleared Oct 05, 1993
CANDELA MINIBRUSH
K932930 · FEB
Candela Laser Corp.
General Hospital · 112d
Cleared Jan 15, 1993
CANDELA LASSER SYSTEMS MODIFIED
K924158 · GEX
Candela Laser Corp.
General & Plastic Surgery · 150d
Cleared Jun 05, 1992
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LAS.
K920062 · GEX
Candela Laser Corp.
General & Plastic Surgery · 150d
Cleared Jan 23, 1992
CANDELA RETINAL CAMERA
K913314 · HKI
Candela Laser Corp.
Ophthalmic · 182d
Cleared Aug 16, 1991
CANDELA INTRODUCER SHEATH SYSTEM
K912443 · FDE
Candela Laser Corp.
Gastroenterology & Urology · 74d
Cleared Apr 12, 1991
CANDELA MINI-UB ENDOSCOPE
K910732 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 50d
Cleared Mar 04, 1991
CANDELA DIODE TRABECULOPLASTY LASER DTL
K910612 · HQF
Candela Laser Corp.
Ophthalmic · 20d
Cleared Oct 03, 1990
CANDELA SPTL-1 LASER FOR TREATING BENIGN VASC. LES
K900858 · GEX
Candela Laser Corp.
General & Plastic Surgery · 222d
Cleared Jul 13, 1990
MDL-2000 LASERTRIPTER
K901723 · LNK
Candela Laser Corp.
Gastroenterology & Urology · 88d
Cleared May 11, 1990
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
K900904 · FGE
Candela Laser Corp.
Gastroenterology & Urology · 73d
Cleared Aug 02, 1989
CANDELA UPC LASER PHOTOCOAGULATOR
K893630 · HQF
Candela Laser Corp.
Ophthalmic · 83d
Cleared Jun 15, 1989
CANDELA PLDL-1 PULSED DYE LASER
K892516 · GEX
Candela Laser Corp.
General & Plastic Surgery · 65d
Cleared Jun 01, 1989
MDL-1 LASERTRIPTER(TM)
K885255 · FFK
Candela Laser Corp.
Gastroenterology & Urology · 160d
Cleared Feb 09, 1989
CANDELA STONE BASKETS
K884738 · FFL
Candela Laser Corp.
Gastroenterology & Urology · 87d
Cleared Dec 28, 1988
CANDELA MINIFLEX DEFLECTABLE URETEROSCOPE
K884153 · FGB
Candela Laser Corp.
Gastroenterology & Urology · 89d
Cleared Jul 05, 1988
SPTL-1 PULSED DYE LASER
K882243 · GEX
Candela Laser Corp.
General & Plastic Surgery · 35d
Cleared Jun 17, 1988
MDL-1 LASERTRIPTER
K880503 · FFK
Candela Laser Corp.
Gastroenterology & Urology · 130d
Cleared Feb 19, 1988
LASERTRIPTER MINISCOPE
K874858 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 86d