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."
1–24 of 48
Search insights Median review: 87d Cleared: 100% Top manufacturer: Candela Corp. Lead specialty: General & Plastic Surgery
Cleared Feb 01, 2019
Vbeam Prima Laser System
K183452 · GEX
Candela Corp.
General & Plastic Surgery · 50d
Cleared Nov 07, 2014
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K140732 · GEX
Candela Corp.
General & Plastic Surgery · 228d
Cleared May 09, 2014
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
K140122 · GEX
Candela Corp.
General & Plastic Surgery · 113d
Cleared Dec 26, 2013
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
K133283 · GEX
Candela Corp.
General & Plastic Surgery · 62d
Cleared Oct 05, 2011
CANDELA GENTLEMAX FAMILY OF LASERS
K112715 · GEX
Candela Corp.
General & Plastic Surgery · 16d
Cleared Jul 18, 2011
CANDELA GENTLELASE FAMILY OF LASERS
K111144 · GEX
Candela Corp.
General & Plastic Surgery · 87d
Cleared Jun 17, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
K081324 · GEX
Candela Corp.
General & Plastic Surgery · 36d
Cleared Apr 03, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
K073534 · GEX
Candela Corp.
General & Plastic Surgery · 108d
Cleared Aug 15, 2007
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
K071469 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Feb 05, 2007
CANDELA FLUORESCENT PULSED LIGHT SYSTEM
K063800 · GEX
Candela Corp.
General & Plastic Surgery · 45d
Cleared Dec 27, 2006
CANDELA 3630 LASER SYSTEM
K063074 · GEX
Candela Corp.
General & Plastic Surgery · 82d
Cleared Dec 20, 2006
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
K063073 · GEX
Candela Corp.
General & Plastic Surgery · 75d
Cleared Dec 20, 2006
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND...
K063072 · GEX
Candela Corp.
General & Plastic Surgery · 75d
Cleared Jul 13, 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY
K051359 · GEX
Candela Corp.
General & Plastic Surgery · 50d
Cleared Jun 13, 2005
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS
K050673 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Feb 09, 2005
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B
K043251 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Nov 22, 2004
CANDELA SMOOTHBEAM LASER SYSTEM
K041242 · GEX
Candela Corp.
General & Plastic Surgery · 195d
Cleared Jan 16, 2004
CANDELA VBEAM PULSE DYE LASER SYSTEM
K033461 · GEX
Candela Corp.
General & Plastic Surgery · 78d
Cleared Jan 16, 2004
CANDELA CBEAM PULSE DYE LASER SYSTEM
K033331 · GEX
Candela Corp.
General & Plastic Surgery · 92d
Cleared Dec 03, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030834 · GEX
Candela Corp.
General & Plastic Surgery · 261d
Cleared Oct 30, 2003
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS
K033172 · GEX
Candela Corp.
General & Plastic Surgery · 30d
Cleared Sep 16, 2003
CANDELA SMOOTHBEAM LASER SYSTEM
K030846 · GEX
Candela Corp.
General & Plastic Surgery · 183d
Cleared Mar 31, 2003
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM
K024371 · GEX
Candela Corp.
General & Plastic Surgery · 90d
Cleared Mar 21, 2003
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
K024260 · GEX
Candela Corp.
General & Plastic Surgery · 88d