FDA.reportPublic FDA data

Candela Corporation

Matched from indexed company URL: CANDELA CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30164966623016496662Candela Corporation1N2026-01-01251 Locke Drive Marlborough MA US 01752
12184021218402CANDELA CORPORATION1Y2020-04-25530 Boston Post Rd Wayland MA US 01778

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00817495024325Standard 64 Sublative iD, (400 Pulse), 10-Pk - KT729518007352737customerservice@syneron-candela.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2384491991905065K240070Profound MatrixGEI2024-07-01
2384491500773979K232977Biophotas Celluma CONTOUROLI2023-11-21
2384491003990168K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)GEX2023-06-01
2384491110844106K220853PicoWay Laser SystemGEX2022-10-13
2384491770940945K212492Frax 1940 for Nordlys and Frax ProGEX2021-12-20
2384491106143711K201111GentleMax Pro PlusGEX2020-05-26
12951667993063K191685PicoWay Laser SystemGEX2019-09-16
2384491667993063K191685PicoWay Laser SystemGEX2019-09-16
12951791229791K183452Vbeam Prima Laser SystemGEX2019-02-01
2384491791229791K183452Vbeam Prima Laser SystemGEX2019-02-01
2384491874744155K181523Syneron CO2RE SystemGEX2018-07-11
2384491494090761K180406Ellipse YdunGEX2018-03-15
2384491722904197K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraGEX2016-09-16
2384491540642502K161043Profound SystemPBX2016-09-12
2384491040208425K152280BioPhotas Celluma3ILY2016-03-02
2384491970741912K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner, Ellipse Nordlys UltraGEX2015-07-07
2384491825007245K141507TWO SKIN TREATMENT SYSTEMGEI2014-12-08
12952008777257K140732CANDELA GENTLELASE FAMILY OF LASER SYSTEMSGEX2014-11-07
2384492008777257K140732CANDELA GENTLELASE FAMILY OF LASER SYSTEMSGEX2014-11-07
12951692739503K140122CANDELA GENTLEMAX FAMILY OF LASER SYSTEMGEX2014-05-09
2384491692739503K140122CANDELA GENTLEMAX FAMILY OF LASER SYSTEMGEX2014-05-09
2384492026831263K122579VELASHAPENUV2012-09-13
2384491704815172K113868EPLUS SKIN TREATMENT SYSTEMGEX2012-06-11
12951726744412K081324CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERSGEX2008-06-17
2384491726744412K081324CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERSGEX2008-06-17
12951005160719K043251CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1BGEX2005-02-09
2384491005160719K043251CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1BGEX2005-02-09
12951170648996K033172CANDELA GENTLEYAG FAMILY OF LASER SYSTEMSGEX2003-10-30
2384491170648996K033172CANDELA GENTLEYAG FAMILY OF LASER SYSTEMSGEX2003-10-30
12952023321833K001589CANDELA DYNAMIC COOLING DEVICEGEX2000-08-18
2384492023321833K001589CANDELA DYNAMIC COOLING DEVICEGEX2000-08-18
2384491433283481

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX272023-06-01
GEI22024-07-01
OLI12023-11-21
PBX12016-09-12
ILY12016-03-02
NUV12012-09-13

PMN#

GUDID#

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