Candela Corp

FDA Filings

This page includes the latest FDA filings for Candela Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Candela Corp holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1218402
FEI Number1218402
NameCANDELA CORPORATION
Owner & OperatorCandela Corporation
Contact Address530 Boston Post Road --
Wayland MA 01778 US
Official Correspondent
  • Yverre Bobay
  • x-508-3587400-3220
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address530 Boston Post Rd
Wayland, MA 01778 US
Establishment TypeManufacture Medical Device



Registration Number3016496662
FEI Number3016496662
NameCandela Corporation
Owner & OperatorCandela Corporation
Contact Address530 Boston Post Road --
Wayland MA 01778 US
Official Correspondent
  • Yverre Bobay
  • x-508-3587400-3220
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address251 Locke Drive
Marlborough, MA 01752 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
Candela Corporation
Profound Matrix2021-12-16
CANDELA CORPORATION
Alex 2021-08-24
CANDELA CORPORATION
ALEX TriVantage 9914-00-2025 2021-08-24
CANDELA CORPORATION
PicoWay 730nm Handpiece 2021-05-24
CANDELA CORPORATION
FSE ALEX2 1064 HP ASSY 2021-05-24
CANDELA CORPORATION
FSE ALEX2 532 HP ASSY 2021-05-24
CANDELA CORPORATION
GentleLase 12/15/18MM RGD Delivery System W/O Fiber 2021-05-24
CANDELA CORPORATION
GentleLase 6/8/10MM RGD Delivery System W/O Fiber 2021-05-24
CANDELA CORPORATION
GentleYAG 6/8/10MM RGD Delivery System W/O Fiber 2021-05-24
CANDELA CORPORATION
GentleLase 12/15/18 RGD Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG 3MM Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG 3MM Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG 12/15/18 Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG 12/15/18 Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG 6/8/10 Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG 6/8/10 Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleLase LE 12MM Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleLase LE 12MM Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG LE Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG LE Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleLase LE Delivery System W/O 2021-05-24
CANDELA CORPORATION
GentleYAG 6/8/10 RGD Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
VPYAG 6/8/10MM RGD Fiber 7122-00-38352021-05-24
CANDELA CORPORATION
VPYAG 12/15/18MM RGD Fiber 7122-00-37952021-05-24
CANDELA CORPORATION
MGL 12/15/18MM RGD Fiber 7122-00-37892021-05-24
CANDELA CORPORATION
Fiber Cable Assembly 7122-20-31412021-05-24
CANDELA CORPORATION
Fiber Cable Assembly 7122-00-36712021-05-24
CANDELA CORPORATION
Open 2021-05-24
CANDELA CORPORATION
MGL-LE 10/12/15MM RGD Fiber 7122-00-75482021-05-24
CANDELA CORPORATION
MGL 6/8/10MM RGD Fiber 7122-00-38332021-05-24
CANDELA CORPORATION
GentleYAG 1.5/3MM Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleLase LE 10/12/15 RGD Delivery System 2021-05-24
CANDELA CORPORATION
GentleLase 6/8/10MM RGD Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleLase 12/15/18MM RGD Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleLase LE Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
Vbeam Delivery System W/Fiber 2021-05-24
CANDELA CORPORATION
GentleYAG SR/VR Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG HR/VR Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG HR/SRT Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG VR Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG SRT Delivery System W/O DCD 2021-05-24
CANDELA CORPORATION
GYAG,HR DLVY SYS W/O DCD 2021-05-24
CANDELA CORPORATION
GentleYAG SR Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG SR Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG SR Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG SR Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG SR Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG SR Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG HR Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG LE 3MM Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleYAG LE 8MM RGD Delivery System 2021-05-24
CANDELA CORPORATION
GentleYAG LE 12MM RGD Delivery System 2021-05-24
CANDELA CORPORATION
GentleYAG 1.5/3MM Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
ALEX2 5MM SPOT SIZE ASSY 2021-05-24
CANDELA CORPORATION
GentleYAG 12/15/18MM RGD Delivery System W/O Fiber 2021-05-24
CANDELA CORPORATION
GentleYAG 6/8/10MM RGD Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
GentleLase Handpiece Assembly 2021-05-24
CANDELA CORPORATION
GentleYAG 12/15/18 RGD Delivery System W/DCD 2021-05-24
CANDELA CORPORATION
Vbeam Prima Base Laser System with 1064 2021-01-26
CANDELA CORPORATION
Vbeam Prima Base Laser System with Contact Cooling, JP 2021-01-26
CANDELA CORPORATION
Vbeam Prima Base Laser System, JP 2021-01-26
CANDELA CORPORATION
VBeam Prima Laser System, JP 2021-01-26
CANDELA CORPORATION
Frax Pro System - CE Configuration 2021-01-25
CANDELA CORPORATION
Frax Pro 2021-01-25
CANDELA CORPORATION
Sirius 2021-01-25
CANDELA CORPORATION
Nordlys 2021-01-25
CANDELA CORPORATION
Applicator Frax 1940 1940 nm 2021-01-25
CANDELA CORPORATION
Applicator Frax 1550 1550 nm 2021-01-25
CANDELA CORPORATION
Applicator PRS 530 530 - 750 nm 2021-01-25
CANDELA CORPORATION
Applicator VLS 555 555 - 950 nm 2021-01-25
CANDELA CORPORATION
Applicator HR 600 600 - 950 nm 2021-01-25
CANDELA CORPORATION
Applicator HRL 600 600 - 950 nm 2021-01-25
CANDELA CORPORATION
Applicator HRD 645 645 - 950 nm 2021-01-25
CANDELA CORPORATION
Applicator VL 555 555 - 950 nm 2021-01-25
CANDELA CORPORATION
Applicator PR 530 530 - 750 nm 2021-01-25
CANDELA CORPORATION
Applicator PL 400 400 - 720 nm 2021-01-25
CANDELA CORPORATION
Applicator Nd:YAG 1064 nm 2021-01-25
CANDELA CORPORATION
FSE, PicoWay 785nm Handpiece 2020-08-05
CANDELA CORPORATION
FSE, PicoWay 785nm Handpiece 2020-08-03
CANDELA CORPORATION
PicoWay Zoom Handpiece Kit 2020-08-03
CANDELA CORPORATION
VBeam Prima DCD Delivery System 2020-08-03
CANDELA CORPORATION
VBeam Prima CC Delivery System 2020-08-03
CANDELA CORPORATION
VBEAM Prima Laser System 2020-08-03
CANDELA CORPORATION
VBEAM Prima without Contact Cooling 2020-08-03
CANDELA CORPORATION
VBEAM Prima without 1064 nm 2020-08-03
CANDELA CORPORATION
VBEAM Prima without Contact Cooling or 1064 nm 2020-08-03
CANDELA CORPORATION
Kit, PicoWay 532nm Resolve Fusion HP 2020-08-03
CANDELA CORPORATION
Kit, PicoWay 532 HE Resolve HP 2020-08-03
CANDELA CORPORATION
Kit, PicoWay 532nm Resolve HP 2020-08-03
CANDELA CORPORATION
Kit, PicoWay 1064nm Resolve HP 2020-08-03
CANDELA CORPORATION
Kit, PicoWay 730nm Handpiece 2020-08-03
CANDELA CORPORATION
PicoWay 532nm Resolve Fusion Handpiece 2020-08-03
CANDELA CORPORATION
GentleMax 2020-08-03
CANDELA CORPORATION
GentleYAG 2020-08-03
CANDELA CORPORATION
Vbeam Platinum 2020-08-03
CANDELA CORPORATION
Cbeam 7MM Handpiece Assembly 2020-07-01
CANDELA CORPORATION
Cbeam 5MM Handpiece Assembly 2020-07-01
CANDELA CORPORATION
Cbeam 10MM Handpiece Assembly 2020-07-01
CANDELA CORPORATION
GentleMax 2020-07-01
CANDELA CORPORATION
GentleMax 2020-07-01
Candela Corporation
GentleMax Pro Plus2020-05-26
Candela Corporation
Ydun2020-02-07
Candela Corporation
Nordlys2020-02-07
Candela Corporation
Sirius2020-02-07
Candela Corporation
Sirius2020-02-07
Candela Corporation
CO2RE, CO2RE Intima2019-12-20
Candela Corporation
Profound2019-12-20
Candela Corporation
Profound2019-12-20
Candela Corporation
eTwo2019-12-20
Candela Corporation
Velashape, Velashape II2019-12-20
Candela Corporation
Elos Plus2019-12-20
Candela Corporation
Picoway System and accessories2019-09-24
CANDELA CORPORATION
Picoway System and accessories2019-09-24
Candela Corporation
PicoWay Laser System2019-09-16
Candela Corporation
Vbeam Prima2019-02-04
Candela Corporation
Vbeam Prima Laser System2019-02-04
CANDELA CORPORATION
Vbeam Prima2019-02-04
CANDELA CORPORATION
Vbeam Prima Laser System2019-02-04
Candela Corp.
Vbeam Prima Laser System2019-02-01
Candela Corporation
PicoWay Laser System2015-04-16
Candela Corporation
GentleTouch2014-11-10
Candela Corporation
GentleLase Pro2014-11-10
Candela Corporation
GentleLase Pro LE2014-11-10
CANDELA CORPORATION
GentleTouch2014-11-10
CANDELA CORPORATION
GentleLase Pro2014-11-10
CANDELA CORPORATION
GentleLase Pro LE2014-11-10
CANDELA CORP.
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2014-11-07
Candela Corporation
GentleMax Pro2014-05-19
CANDELA CORPORATION
GentleMax Pro2014-05-19
Candela Corporation
GentleMax Pro2014-05-19
CANDELA CORPORATION
GentleMax Pro2014-05-19
CANDELA CORP.
CANDELA GENTLEMAX FAMILY OF LASER SYSTEM2014-05-09
CANDELA CORP.
CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS2013-12-26
CANDELA CORP.
CANDELA GENTLEMAX FAMILY OF LASERS2011-10-05
CANDELA CORP.
CANDELA GENTLELASE FAMILY OF LASERS2011-07-18
Candela Corporation
Candela Q-Switched Alexandrite Laser2010-12-07
Candela Corporation
Alex Trivantage2010-12-07
CANDELA CORPORATION
Candela Q-Switched Alexandrite Laser2010-12-07
CANDELA CORPORATION
Alex Trivantage2010-12-07
CANDELA CORP.
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASERS2008-06-17
CANDELA CORP.
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS2008-04-03
Candela Corporation
GentleYag Pro U2008-01-29
Candela Corporation
GentleYAG2008-01-29
Candela Corporation
GentleYAG LE2008-01-29
CANDELA CORPORATION
GentleYag Pro U2008-01-29
CANDELA CORPORATION
GentleYAG2008-01-29
CANDELA CORPORATION
GentleYAG LE2008-01-29
Candela Corporation
Vbeam Perfecta, Vbeam Platinum, Vbeam Aesthetica2008-01-28
Candela Corporation
Vbeam II2008-01-28
CANDELA CORPORATION
Vbeam Perfecta, Vbeam Platinum, Vbeam Aesthetica2008-01-28
CANDELA CORPORATION
Vbeam II2008-01-28
CANDELA CORPORATION
Candela Dynamic Cooling Device2008-01-25
CANDELA CORP.
INOLASE SERENITY PSF ( PNEUMATIC SKIN FLATTENING) SYSTEM2007-08-15
CANDELA CORP.
CANDELA FLUORESCENT PULSED LIGHT SYSTEM2007-02-05
CANDELA CORP.
CANDELA 3630 LASER SYSTEM2006-12-27
CANDELA CORP.
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS: PIGMENTED LESION HANDPIECE ACCESSORY2005-07-13
CANDELA CORP.
CANDELA FAMILY OF PULSE DYE LASER SYSTEMS2005-06-13
CANDELA CORP.
CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1B2005-02-09
CANDELA CORP.
CANDELA VBEAM PULSE DYE LASER SYSTEM2004-01-16
CANDELA CORP.
CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS2003-10-30
CANDELA CORP.
CANDELA SMOOTHBEAM LASER SYSTEM2003-09-16
CANDELA CORP.
CANDELA GENTLE LASE FAMILY OF LASER SYSTEM2003-03-31
CANDELA CORP.
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2003-03-21
CANDELA CORP.
CANDELA GENTLE YAG LASER SYSTEM2003-03-13
CANDELA CORP.
CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2003-03-12
CANDELA CORP.
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG2003-01-27
CANDELA CORP.
CANDELA SMOOTHBEAM LASER SYSTEM2003-01-22
CANDELA CORP.
CANDELA SMOOTHBEAM LASER SYSTEM2002-10-04
CANDELA CORP.
CANDELA VBEAM PULSED DYE LASER SYSTEM2002-07-02
CANDELA CORP.
CANDELA CBEAM PULSED DYE LASER SYSTEM2002-06-21
CANDELA CORP.
CANDELA SMOOTHBEAM LASER SYSTEM2002-02-15
CANDELA CORP.
CANDELA SCLERO LONG PULSE LASER (AKA VBEAM)2002-02-11
CANDELA CORP.
CANDELA CLEARBEAM PULSED DYE LASER2001-10-11
CANDELA CORP.
CANDELA SPTL-1E PULSED DYE LASER2001-07-09
CANDELA CORP.
CANDELA LONG PULSE ND:YAG2001-04-11
CANDELA CORP.
CANDELA MID IR DIODE LASER SYSTEM2000-11-03
CANDELA CORP.
CANDELA SPTL-1B PULSED DYE LASER2000-09-19
CANDELA CORP.
CANDELA DYNAMIC COOLING DEVICE2000-08-18
CANDELA CORP.
CANDELA GENTLELASE GL DERMATOLOGICAL LASER2000-05-26
CANDELA CORP.
CANDELA SCLERO LONG PULSE DYE LASER2000-01-24
CANDELA CORP.
CANDELA GENTLELASE II DERMATOLOGICAL LASER1999-02-04
CANDELA CORP.
CANDELA GENTLELASE GL DERMATOLOGICAL LASER1998-07-13
CANDELA CORP.
CANDELA GENTLELASE GL DERMATOLOGICAL LASER1998-02-10
CANDELA CORP.
CANDELA GENTLELASE GL DERMATOLOGICAL VASCULAR LESION LASER1997-12-04
CANDELA CORP.
CANDELA MODEL MDL-1 LASER LITHOTRIPTOR1986-12-03
CANDELA CORP.
CANDELA MODEL SPT-1, PULSED DYE LASER1986-11-20

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