Candela Corp. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Candela Corp. - FDA 510(k) Cleared Devices
Recent clearances: Vbeam Prima Laser System
48
Total
48
Cleared
0
Denied
Candela Corp. has 48 FDA 510(k) cleared general & plastic surgery devices. Based in Natick, US.
Historical record: 48 cleared submissions from 1986 to 2019.
Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Candela Corp.
48 devices
Cleared
Feb 01, 2019
Vbeam Prima Laser System
General & Plastic Surgery
50d
Cleared
Nov 07, 2014
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS
General & Plastic Surgery
228d
Cleared
May 09, 2014
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM
General & Plastic Surgery
113d
Cleared
Dec 26, 2013
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS
General & Plastic Surgery
62d
Cleared
Oct 05, 2011
CANDELA GENTLEMAX FAMILY OF LASERS
General & Plastic Surgery
16d
Cleared
Jul 18, 2011
CANDELA GENTLELASE FAMILY OF LASERS
General & Plastic Surgery
87d
Cleared
Jun 17, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS
General & Plastic Surgery
36d
Cleared
Apr 03, 2008
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS
General & Plastic Surgery
108d
Cleared
Aug 15, 2007
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM
General & Plastic Surgery
78d
Cleared
Feb 05, 2007
CANDELA FLUORESCENT PULSED LIGHT SYSTEM
General & Plastic Surgery
45d
Cleared
Dec 27, 2006
CANDELA 3630 LASER SYSTEM
General & Plastic Surgery
82d
Cleared
Dec 20, 2006
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND...
General & Plastic Surgery
75d
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