Candela Corp.

Medical device manufacturer in Marlborough, MA.

56510(k) clearances
0PMA approvals
5recalls

Device types

510(k) clearances

510(k)DeviceDecision
K240070Profound MatrixGEI · Traditional 07/01/2024SE
K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)GEX · Traditional 06/01/2023SE
K220853PicoWay Laser SystemGEX · Traditional 10/13/2022SE
K212492Frax 1940 for Nordlys and Frax ProGEX · Traditional 12/20/2021SE
K211217Profound MatrixGEI · Traditional 12/16/2021SE
K201111GentleMax Pro PlusGEX · Special 05/26/2020SE
K191685PicoWay Laser SystemGEX · Traditional 09/16/2019SE
K183452Vbeam Prima Laser SystemGEX · Special 02/01/2019SE
K150326PicoWay Laser SystemGEX · Traditional 04/16/2015SE
K140732Candela Gentlelase Family of Laser SystemsGEX · Special 11/07/2014SE
K140122Candela Gentlemax Family of Laser SystemGEX · Traditional 05/09/2014SE
K133283Candela Gentlemax Family of Laser SystemsGEX · Special 12/26/2013SE
K112715Candela Gentlemax Family of LasersGEX · Traditional 10/05/2011SE
K111144Candela Gentlelase Family of LasersGEX · Traditional 07/18/2011SE
K081324Candela Family of Q-Switched Alexandrite LasersGEX · Special 06/17/2008SE
K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsGEX · Traditional 04/03/2008SE
K071469Inolase Serenity PSF ( Pneumatic Skin Flattening) SystemGEX · Traditional 08/15/2007SE
K063800Candela Fluorescent Pulsed Light SystemGEX · Traditional 02/05/2007SE
K063074Candela 3630 Laser SystemGEX · Traditional 12/27/2006SE
K063073Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsGEX · Traditional 12/20/2006SE
K063072Candela Family of Q-Switched Alexandrite Laser (Alexlazr) Systems: 532 and 1064 Nd:Yag…GEX · Traditional 12/20/2006SE
K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryGEX · Traditional 07/13/2005SE
K050673Candela Family of Pulse Dye Laser SystemsGEX · Traditional 06/13/2005SE
K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BGEX · Traditional 02/09/2005SE
K041242Candela Smoothbeam Laser SystemGEX · Traditional 11/22/2004SE
K033461Candela Vbeam Pulse Dye Laser SystemGEX · Traditional 01/16/2004SE
K033331Candela Cbeam Pulse Dye Laser SystemGEX · Traditional 01/16/2004SE
K030834Candela Smoothbeam Laser SystemGEX · Traditional 12/03/2003SE
K033172Candela Gentleyag Family of Laser SystemsGEX · Traditional 10/30/2003SE
K030846Candela Smoothbeam Laser SystemGEX · Traditional 09/16/2003SE
K024371Candela Gentle Lase Family of Laser SystemGEX · Traditional 03/31/2003SE
K024260Candela Gentlelase Family of Laser SystemsGEX · Traditional 03/21/2003SE
K022923Candela Gentle Yag Laser SystemGEX · Traditional 03/13/2003SE
K024335Candela Gentlelase Family of Laser SystemsGEX · Traditional 03/12/2003SE
K022951Candela Gentle Yag Laser System, Variable Pulse YagGEX · Traditional 01/27/2003SE
K022884Candela Smoothbeam Laser SystemGEX · Traditional 01/22/2003SE
K023193Candela Gentle Yag Laser SystemGEX · Traditional 12/20/2002SE
K014128Candela Smoothbeam Laser SystemGEX · Traditional 10/04/2002SE
K021180Candela Vbeam Pulsed Dye Laser SystemGEX · Traditional 07/02/2002SE
K020958Candela Cbeam Pulsed Dye Laser SystemGEX · Traditional 06/21/2002SE
K013825Candela Smoothbeam Laser SystemGEX · Traditional 02/15/2002SE
K013748Candela Sclero Long Pulse Laser (Aka Vbeam)GEX · Traditional 02/11/2002SE
K013043Candela Clearbeam Pulsed Dye LaserGEX · Traditional 10/11/2001SE
K011092Candela SPTL-1E Pulsed Dye LaserGEX · Traditional 07/09/2001SE
K010104Candela Long Pulse Nd:YagGEX · Traditional 04/11/2001SE
K002421Candela Mid Ir Diode Laser SystemGEX · Traditional 11/03/2000SE
K001093Candela SPTL-1B Pulsed Dye LaserGEX · Traditional 09/19/2000SE
K001589Candela Dynamic Cooling DeviceGEX · Traditional 08/18/2000SE
K994260Candela Gentlelase GL Dermatological LaserGEX · Traditional 05/26/2000SE
K993671Candela Sclero Long Pulse Dye LaserGEX · Traditional 01/24/2000SE
K984601Candela Gentlelase II Dermatological LaserGEX · Traditional 02/04/1999SE
K981351Candela Gentlelase GL Dermatological LaserGEX · Traditional 07/13/1998SE
K974381Candela Gentlelase GL Dermatological LaserGEX · Traditional 02/10/1998SE
K972767Candela Gentlelase GL Dermatological Vascular Lesion LaserGEX · Traditional 12/04/1997SE
K863642Candela Model MDL-1 Laser LithotriptorFFK · Traditional 12/03/1986SE
K861179Candela Model SPT-1, Pulsed Dye LaserGEX · Traditional 11/20/1986SE

Recalls

RecallProductInitiated
Z-0209-2020 Class IICanister HFC-134a /980g, ALUM, 15 pack Product Number: 1600-00-0224 Revision .0C Coolant…The canister neck bushing may become loose and separate from the body of the canister during use. The issue… 09/10/2019Terminated
Z-0208-2020 Class IICanister HFC-134a / 980g, ALUM Product Number: 1600-00-0223 Revision .0C Coolant…The canister neck bushing may become loose and separate from the body of the canister during use. The issue… 09/10/2019Terminated
Z-0207-2020 Class IICanister HFC-134a /1000g, ALUM, 15 pack Product Number: 1600-00-0219 Revision .0C…The canister neck bushing may become loose and separate from the body of the canister during use. The issue… 09/10/2019Terminated
Z-0206-2020 Class IICanister HFC-134a /1000g, ALUM Product Number: 1600-00-0218 Revision .0C Coolant…The canister neck bushing may become loose and separate from the body of the canister during use. The issue… 09/10/2019Terminated
Z-0348-2014 Class IICandela Laser GentleLase Pro, Powered Laser Surgical Instrument for dermatological use -…Unintended single pulse maybe emitted to handpiece prior to pressing of trigger or footswitch and cause… 11/06/2013Terminated