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
 PicoWay Laser System 2024-10-21
Candela Corporation
 PicoWay Laser System 2024-10-14
Candela Corporation
 PicoWay Laser System 2024-10-14
Candela Corporation
 PicoWay Laser System 2024-10-08
Candela Corporation
 GMAX Pro Plus Laser System 9914-CH-90362024-10-02
Candela Corporation
 GMAX Pro Laser System 9914-CH-90352024-10-02
Candela Corporation
 Glase Pro U Laser System 2024-10-02
Candela Corporation
 GYAG Pro U Laser System 9914-CH-90202024-10-02
Candela Corporation
 GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly 7123-CE-06532024-09-05
Candela Corporation
 GMPP DCD Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly 7123-CE-06522024-09-05
Candela Corporation
 ASSY, DCD HAND PIECE, LARGE SPOT, GMPP 7123-CE-06312024-09-05
Candela Corporation
 ASSY, ACC HAND PIECE, LARGE SPOT, GMPP 7123-CE-06282024-09-05
Candela Corporation
 MSDS DCD Option Kit GMPP FIN1033372024-07-04
Candela Corporation
 Modified LSDS Fiber Assembly, 12-26 mm SBA1007752024-06-25
Candela Corporation
 GentleCool Pro Packaged 15-Pack of Cryogen (R134a / 980g / US) FIN1033212024-05-31
Candela Corporation
 GentleCool Pro Canister Cryogen (R134a / 980g / US) FIN1033202024-05-31
Candela Corporation
 Packaged 15-Pack of Cryogen (R134a / 980g / JP) 2024-05-06
Candela Corporation
 Packaged 15-Pack of Cryogen (R134a / 980g / US) 2024-05-06
Candela Corporation
 Profound, Dermal Single- Use Cartridge, Packaged 2024-03-08
Candela Corporation
 Profound, SubQ Single- Use Cartridge, Packaged 2024-03-08
Candela Corporation
 HRDS Handpiece Air Cooled 2024-02-28
Candela Corporation
 HRDS Handpiece DCD Cooled 2024-02-28
Candela Corporation
 GMPP Modified LSDS (HRDS) Options Kit for ACC 2024-02-28
Candela Corporation
 GMPP Modified LSDS (HRDS) Options Kit for DCD 2024-02-28
Candela Corporation
 Canister HFO-R1234 ZE / 950g, ALUM, 15 Pack (Japan) 2024-02-12
Candela Corporation
 Canister HFO-R1234 ZE / 950g, ALUM, 15 Pack (US) 2024-02-12
Candela Corporation
 Canister HFO-R1234 ZE / 950g, ALUM, 3 Pack (Japan) 2024-02-12
Candela Corporation
 Canister HFO-R1234 ZE / 950g, ALUM, 3 Pack (US) 2024-02-12
Candela Corporation
 Canister HFO-R1234 ZE / 950g, ALUM (Japan) 2024-02-12
Candela Corporation
 Canister HFO-R1234 ZE / 950g, ALUM (US) 2024-02-12
Candela Corporation
 Sublative RF applicator FG705412023-10-30
Candela Corporation
 CO2RE Intima 2023-10-30
Candela Corporation
 Regular Internal Handpiece Sterile Single-Use, CO2RE Intima 2023-10-30
Candela Corporation
 SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III KT756722023-10-30
Candela Corporation
 SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape III KT750722023-10-30
Candela Corporation
 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima KT779112023-10-30
Candela Corporation
 Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima KT778212023-10-30
Candela Corporation
 eTwo System FG705032023-10-30
Candela Corporation
 Intima Sterile 2 Internal + 1 External HP, Accessories Kit KT780112023-10-30
Candela Corporation
 SA Small Repl. Cover 10x13mm, 4Hr, Velashape III AS833222023-10-30
Candela Corporation
 Standard 64 Sublative iD, (400 Pulse), Sterile AS793432023-10-30
Candela Corporation
 Standard 64 Sublative iD, (100 Pulse), Sterile AS792532023-10-30
Candela Corporation
 Lens, Gold & Silver AS920412023-10-30
Candela Corporation
 SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III 2023-10-30
Candela Corporation
 SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III AS875122023-10-30
Candela Corporation
 Intima hygienic Accessories Kit, CO2RE KT770032023-10-30
Candela Corporation
 Standard Hand-piece packing Assy, CO2RE AS904112023-10-30
Candela Corporation
 Hand Piece, external hygienic, Packaged, CO2RE AS902452023-10-30
Candela Corporation
 CO2RE Intima 2023-10-30
Candela Corporation
 5-Pk, external hygienic, CO2RE Intima KT766852023-10-30
Candela Corporation
 5-Pk, Internal hygienic, CO2RE Intima KT766162023-10-30
Candela Corporation
 Standard 2 Hand-piece packing Assy, CO2RE AS875322023-10-30
Candela Corporation
 Standard Hand-piece packing Assy, CO2RE AS854212023-10-30
Candela Corporation
 Motif IR Applicator, elos Plus FG709112023-10-30
Candela Corporation
 Standard 64 Sublative iD, (200 Pulse), 10-Pk KT729512023-10-30
Candela Corporation
 Standard 64 Sublative iD, (100 Pulse), 10-Pk KT728612023-10-30
Candela Corporation
 SubRF Std. 64 Tip,Fuse (100 Pulse), 10-Pk, SubRF 2023-10-30
Candela Corporation
 CO2RE System for US, Packaged FG70412US2023-10-30
Candela Corporation
 SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III FG70412JP2023-10-30
Candela Corporation
 CO2RE system FG704122023-10-30
Candela Corporation
 SubQ applicator FG715012023-10-30
Candela Corporation
 SRA Plus Mini applicator FG711512023-10-30
Candela Corporation
 SRA Plus applicator FG711412023-10-30
Candela Corporation
 Sublime applicator FG706312023-10-30
Candela Corporation
 SRA applicator FG706212023-10-30
Candela Corporation
 SR applicator FG706112023-10-30
Candela Corporation
 AC Applicator, elos Plus FG705912023-10-30
Candela Corporation
 elos Plus system FG705342023-10-30
Candela Corporation
 Replaceable Cover, Vsmooth 4Hr AS859932023-10-30
Candela Corporation
 Motif Vantage Applicator FG712812023-10-30
Candela Corporation
 Motif LHR applicator FG708712023-10-30
Candela Corporation
 Dermal Single- Use Cartridge 6-Pkg, Profound, KT766532023-10-30
Candela Corporation
 SubQ Single- Use Cartridge 6-Pkg, Profound KT766632023-10-30
Candela Corporation
 LA Replaceable Cover (4 Hr) 5-Pk KT751022023-10-30
Candela Corporation
 SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape III KT750612023-10-30
Candela Corporation
 Profound System, Packaged FG705142023-10-30
Candela Corporation
 Dermal applicator FG705232023-10-30
Candela Corporation
 Motif HR applicator FG709212023-10-30
Candela Corporation
 Sublime applicator FG705512023-10-30
Candela Corporation
 F100mm Lens , CO2RE AS761122023-10-30
Candela Corporation
 F127mm Lens, CO2RE AS761032023-10-30
Candela Corporation
 Vsmooth applicator FG711712023-10-30
Candela Corporation
 Vcontour applicator FG710122023-10-30
Candela Corporation
 Large Spot Fiber Assembly 2023-07-07
Candela Corporation
 FIBER, STANDARD, HC, GMPP 2023-07-07
Candela Corporation
 PRO Series Fiber Assembly 2023-07-07
Candela Corporation
 Large Spot Fiber Assembly 2023-07-07
Candela Corporation
 FIBER, STANDARD, HC, GMPP 2023-07-07
Candela Corporation
 PRO Series Fiber Assembly 2023-07-07
Candela Corporation
 Large Spot Fiber Assembly 2023-07-07
Candela Corporation
 FIBER, STANDARD, HC, GMPP 2023-07-07
Candela Corporation
 PRO Series Fiber Assembly 2023-07-07
Candela Corporation
 Perfecta Delivery System, Refurbished 2023-06-20
Candela Corporation
 Pro Delivery System, Refurbished 2023-05-09
Candela Corporation
 ASSY, DELIVERY SYS, DCD HP, PRIMA REFURBISHED 2023-05-09
Candela Corporation
 FSE, PICO 730 Handpiece Assembly 2023-04-11
Candela Corporation
 Refurbished Picoway 1064 Resolve Handpiece 2023-03-02
Candela Corporation
 Refurbished Picoway Zoom Handpiece 2023-03-02
Candela Corporation
 GentleMAX PRO PLUS Laser System 2022-12-13
Candela Corporation
 Refurbished GentleMax Pro Plus 9914-58-90362022-12-07
Candela Corporation
PicoWay Laser System2022-10-13
Candela Corporation
Profound Matrix2021-12-16
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 SMOOTHBEAM LASER SYSTEM2004-11-22
CANDELA CORP.
CANDELA VBEAM PULSE DYE LASER SYSTEM2004-01-16
CANDELA CORP.
CANDELA SMOOTHBEAM LASER SYSTEM2003-12-03
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 GENTLE YAG LASER SYSTEM2002-12-20
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

Similar & Related FDA Registered Companies

Related Finance Registrations
NCAGE Code0ABZ8CANDELA CORP
NCAGE Code0TFV9CANDELA CORP
NCAGE Code4CWE7CANDELA CORPORATION
NCAGE Code52209CANDELA CORPORATION!DBA SYNERON CANDELA
CAGE Code0ABZ8CANDELA CORP
CAGE Code0TFV9CANDELA CORP
CAGE Code4CWE7CANDELA CORPORATION
CAGE Code52209CANDELA CORPORATION SYNERON CANDELA
S.A.M. Registration52209 [53468385]CANDELA CORPORATION SYNERON CANDELA
SEC0000785756CANDELA CORP
SEC0000793279CANDELA CORP /DE/ of DELAWARE
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020090816609Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyILLUMINANT3 PKG
2020090282852Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseyILLUMINANT3 PKG
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