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Candela Corp.

FDA 510(k) & PMA Approved Devices — 46 products

Total Devices46
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K183452 Vbeam Prima Laser SystemGEX2019-02-01 View
510(k) K133283 CANDELA GENTLEMAX FAMILY OF LASER SYSTEMSGEX2013-12-26 View
510(k) K112715 CANDELA GENTLEMAX FAMILY OF LASERSGEX2011-10-05 View
510(k) K111144 CANDELA GENTLELASE FAMILY OF LASERSGEX2011-07-18 View
510(k) K081324 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERSGEX2008-06-17 View
510(k) K073534 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMSGEX2008-04-03 View
510(k) K071469 INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEMGEX2007-08-15 View
510(k) K063800 CANDELA FLUORESCENT PULSED LIGHT SYSTEMGEX2007-02-05 View
510(k) K063074 CANDELA 3630 LASER SYSTEMGEX2006-12-27 View
510(k) K063073 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMSGEX2006-12-20 View
510(k) K063072 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIESGEX2006-12-20 View
510(k) K051359 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORYGEX2005-07-13 View
510(k) K050673 CANDELA FAMILY OF PULSE DYE LASER SYSTEMSGEX2005-06-13 View
510(k) K043251 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1BGEX2005-02-09 View
510(k) K041242 CANDELA SMOOTHBEAM LASER SYSTEMGEX2004-11-22 View
510(k) K033461 CANDELA VBEAM PULSE DYE LASER SYSTEMGEX2004-01-16 View
510(k) K033331 CANDELA CBEAM PULSE DYE LASER SYSTEMGEX2004-01-16 View
510(k) K030834 CANDELA SMOOTHBEAM LASER SYSTEMGEX2003-12-03 View
510(k) K033172 CANDELA GENTLEYAG FAMILY OF LASER SYSTEMSGEX2003-10-30 View
510(k) K030846 CANDELA SMOOTHBEAM LASER SYSTEMGEX2003-09-16 View
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