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."
1–24 of 43
Search insights Median review: 96d Cleared: 100% Top manufacturer: Candela Laser Corp. Lead specialty: General & Plastic Surgery
Cleared Aug 15, 1996
ANDELA DYNAMIC COOLING DEVICE
K951033 · IMD
Candela Laser Corp.
Physical Medicine · 528d
Cleared Jun 14, 1996
CANDELA Q-SWITCHED ALEXANDRITE LASERS
K955662 · GEX
Candela Laser Corp.
General & Plastic Surgery · 185d
Cleared Apr 03, 1996
CANDELA HCS 2000 URETHERAL WARMER CATHETER
K955011 · GEH
Candela Laser Corp.
General & Plastic Surgery · 154d
Cleared Feb 05, 1996
CANDELA CRYO-PROBE HOLDER
K954872 · GEH
Candela Laser Corp.
General & Plastic Surgery · 104d
Cleared Feb 02, 1996
CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE
K954934 · GEX
Candela Laser Corp.
General & Plastic Surgery · 98d
Cleared Oct 24, 1995
CANDELA MODEL PLTL-1 LASER SYSTEM
K953412 · GEX
Candela Laser Corp.
General & Plastic Surgery · 96d
Cleared Oct 18, 1995
CANDELA CRYOSYSTEM CS-5
K953294 · GEH
Candela Laser Corp.
General & Plastic Surgery · 96d
Cleared May 26, 1995
ALEXLAZR
K950831 · GEX
Candela Laser Corp.
General & Plastic Surgery · 91d
Cleared Mar 24, 1995
CANDELA RUBY LAZE Q-SWITCHED RUBY LASER
K946386 · GEX
Candela Laser Corp.
General & Plastic Surgery · 93d
Cleared Mar 10, 1995
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE
K950661 · GEX
Candela Laser Corp.
General & Plastic Surgery · 25d
Cleared Mar 09, 1995
CANDELA SPTL VARIABLE PULSE/TUNABLE PULSED DYE LASERS
K943292 · GEX
Candela Laser Corp.
General & Plastic Surgery · 244d
Cleared Mar 06, 1995
CANDELA URETHRAL/BLADDER SOUND
K950633 · FBX
Candela Laser Corp.
Gastroenterology & Urology · 21d
Cleared Mar 01, 1995
CANDEKA DUKATIR SETS
K950635 · DQY
Candela Laser Corp.
Cardiovascular · 16d
Cleared Mar 01, 1995
CANDELA SHEATH SETS
K950634 · DQY
Candela Laser Corp.
Cardiovascular · 16d
Cleared Dec 08, 1994
CANDELA ELLIPTICAL SPOT HANDPIECE
K945587 · GEX
Candela Laser Corp.
General & Plastic Surgery · 24d
Cleared Dec 07, 1994
CANDELA Q-SWITCHED ALEXANDRITE LASER
K940173 · GEX
Candela Laser Corp.
General & Plastic Surgery · 330d
Cleared Nov 07, 1994
CANDELA H:ERB LASER
K921995 · GEX
Candela Laser Corp.
General & Plastic Surgery · 923d
Cleared Sep 30, 1994
CANDELA ALEX LAZR Q-SWITCHED ALEXANDRITE LASER
K944090 · GEX
Candela Laser Corp.
General & Plastic Surgery · 39d
Cleared Sep 01, 1994
PLTL-1 & PLDL-1 510NM PULSED DYE LASERS
K934811 · GEX
Candela Laser Corp.
General & Plastic Surgery · 329d
Cleared Jul 25, 1994
CANDELA Q-SWITCHED, FREQUENCY DOUBLED ND
K942152 · GEX
Candela Laser Corp.
General & Plastic Surgery · 83d
Cleared Jun 17, 1994
MINI-UB ENDOSCOPES
K941230 · ODF
Candela Laser Corp.
Gastroenterology & Urology · 94d
Cleared Apr 29, 1994
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR
K934706 · GEX
Candela Laser Corp.
General & Plastic Surgery · 211d
Cleared Mar 15, 1994
CANDELA SPTL PULSED DYE LASERS
K931762 · GEX
Candela Laser Corp.
General & Plastic Surgery · 341d
Cleared Feb 10, 1994
CANDELA GUIDEWIRE
K933268 · NWU
Candela Laser Corp.
Gastroenterology & Urology · 219d