FDA 510(k) Applications Submitted by Candela Corp.

FDA 510(k) Number Submission Date Device Name Applicant
K974381 11/20/1997 CANDELA GENTLELASE GL DERMATOLOGICAL LASER CANDELA CORP.
K981351 04/14/1998 CANDELA GENTLELASE GL DERMATOLOGICAL LASER CANDELA CORP.
K972767 07/24/1997 CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER CANDELA CORP.
K994260 12/17/1999 CANDELA GENTLELASE GL DERMATOLOGICAL LASER CANDELA CORP.
K984601 12/28/1998 CANDELA GENTLELASE II DERMATOLOGICAL LASER CANDELA CORP.
K063073 10/06/2006 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS CANDELA CORP.
K063072 10/06/2006 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS: 532 AND 1064 ND:YAG HANDPIECE ACCESSORIES CANDELA CORP.
K071469 05/29/2007 INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM CANDELA CORP.
K063074 10/06/2006 CANDELA 3630 LASER SYSTEM CANDELA CORP.
K063800 12/22/2006 CANDELA FLUORESCENT PULSED LIGHT SYSTEM CANDELA CORP.
K010104 01/12/2001 CANDELA LONG PULSE ND:YAG CANDELA CORP.
K011092 04/10/2001 CANDELA SPTL-1E PULSED DYE LASER CANDELA CORP.
K002421 08/08/2000 CANDELA MID IR DIODE LASER SYSTEM CANDELA CORP.
K013043 09/10/2001 CANDELA CLEARBEAM PULSED DYE LASER CANDELA CORP.
K993671 11/01/1999 CANDELA SCLERO LONG PULSE DYE LASER CANDELA CORP.
K001093 04/04/2000 CANDELA SPTL-1B PULSED DYE LASER CANDELA CORP.
K001589 05/23/2000 CANDELA DYNAMIC COOLING DEVICE CANDELA CORP.
K013748 11/13/2001 CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) CANDELA CORP.
K081324 05/12/2008 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS CANDELA CORP.
K073534 12/17/2007 CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS CANDELA CORP.
K022884 08/30/2002 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K043251 11/23/2004 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B CANDELA CORP.
K050673 03/15/2005 CANDELA FAMILY OF PULSE DYE LASER SYSTEMS CANDELA CORP.
K030846 03/17/2003 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K041242 05/11/2004 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K051359 05/24/2005 CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY CANDELA CORP.
K033331 10/16/2003 CANDELA CBEAM PULSE DYE LASER SYSTEM CANDELA CORP.
K033461 10/30/2003 CANDELA VBEAM PULSE DYE LASER SYSTEM CANDELA CORP.
K033172 09/30/2003 CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS CANDELA CORP.
K020958 03/25/2002 CANDELA CBEAM PULSED DYE LASER SYSTEM CANDELA CORP.
K021180 04/15/2002 CANDELA VBEAM PULSED DYE LASER SYSTEM CANDELA CORP.
K022923 09/04/2002 CANDELA GENTLE YAG LASER SYSTEM CANDELA CORP.
K022951 09/05/2002 CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG CANDELA CORP.
K013825 11/19/2001 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K014128 12/17/2001 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K030834 03/17/2003 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP.
K140122 01/16/2014 CANDELA GENTLEMAX FAMILY OF LASER SYSTEM CANDELA CORP.
K140732 03/24/2014 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS CANDELA CORP.
K112715 09/19/2011 CANDELA GENTLEMAX FAMILY OF LASERS CANDELA CORP.
K133283 10/25/2013 CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS CANDELA CORP.
K111144 04/22/2011 CANDELA GENTLELASE FAMILY OF LASERS CANDELA CORP.
K183452 12/13/2018 Vbeam Prima Laser System Candela Corp.
K023193 09/25/2002 CANDELA GENTLE YAG LASER SYSTEM CANDELA CORP.
K024260 12/23/2002 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS CANDELA CORP.
K024335 12/27/2002 CANDELA GENTLELASE FAMILY OF LASER SYSTEMS CANDELA CORP.
K024371 12/31/2002 CANDELA GENTLE LASE FAMILY OF LASER SYSTEM CANDELA CORP.


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