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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

48 results for "Candela Corp."
25–48 of 48
Search insights Median review: 87d Cleared: 100% Top manufacturer: Candela Corp. Lead specialty: General & Plastic Surgery
Cleared Mar 13, 2003
CANDELA GENTLE YAG LASER SYSTEM
K022923 · GEX
Candela Corp.
General & Plastic Surgery · 190d
Cleared Mar 12, 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024335 · GEX
Candela Corp.
General & Plastic Surgery · 75d
Cleared Jan 27, 2003
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
K022951 · GEX
Candela Corp.
General & Plastic Surgery · 144d
Cleared Jan 22, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K022884 · GEX
Candela Corp.
General & Plastic Surgery · 145d
Cleared Dec 20, 2002
CANDELA GENTLE YAG LASER SYSTEM
K023193 · GEX
Candela Corp.
General & Plastic Surgery · 86d
Cleared Oct 04, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
K014128 · GEX
Candela Corp.
General & Plastic Surgery · 291d
Cleared Jul 02, 2002
CANDELA VBEAM PULSED DYE LASER SYSTEM
K021180 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Jun 21, 2002
CANDELA CBEAM PULSED DYE LASER SYSTEM
K020958 · GEX
Candela Corp.
General & Plastic Surgery · 88d
Cleared Feb 15, 2002
CANDELA SMOOTHBEAM LASER SYSTEM
K013825 · GEX
Candela Corp.
General & Plastic Surgery · 88d
Cleared Feb 11, 2002
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)
K013748 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Oct 11, 2001
CANDELA CLEARBEAM PULSED DYE LASER
K013043 · GEX
Candela Corp.
General & Plastic Surgery · 31d
Cleared Jul 09, 2001
CANDELA SPTL-1E PULSED DYE LASER
K011092 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Apr 11, 2001
CANDELA LONG PULSE ND:YAG
K010104 · GEX
Candela Corp.
General & Plastic Surgery · 89d
Cleared Nov 03, 2000
CANDELA MID IR DIODE LASER SYSTEM
K002421 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Sep 19, 2000
CANDELA SPTL-1B PULSED DYE LASER
K001093 · GEX
Candela Corp.
General & Plastic Surgery · 168d
Cleared Aug 18, 2000
CANDELA DYNAMIC COOLING DEVICE
K001589 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared May 26, 2000
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K994260 · GEX
Candela Corp.
General & Plastic Surgery · 161d
Cleared Jan 24, 2000
CANDELA SCLERO LONG PULSE DYE LASER
K993671 · GEX
Candela Corp.
General & Plastic Surgery · 84d
Cleared Feb 04, 1999
CANDELA GENTLELASE II DERMATOLOGICAL LASER
K984601 · GEX
Candela Corp.
General & Plastic Surgery · 38d
Cleared Jul 13, 1998
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K981351 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Feb 10, 1998
CANDELA GENTLELASE GL DERMATOLOGICAL LASER
K974381 · GEX
Candela Corp.
General & Plastic Surgery · 82d
Cleared Dec 04, 1997
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER
K972767 · GEX
Candela Corp.
General & Plastic Surgery · 133d
Cleared Dec 03, 1986
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
K863642 · FFK
Candela Corp.
Gastroenterology & Urology · 77d
Cleared Nov 20, 1986
CANDELA MODEL SPT-1, PULSED DYE LASER
K861179 · GEX
Candela Corp.
General & Plastic Surgery · 234d