FDA.reportPublic FDA data

CO2RE System, Packaged (Japan)

Primary DI
00817495024271
Brand
CO2RE System, Packaged (Japan)
Company
Candela Corporation
Model
FG70412JP
Catalog number
FG70412JP
Device description
CO2RE System, Packaged (Japan)
Published
2023-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181523000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181523000Syneron CO2RE SystemSyneron-Candela Corp2018-07-11GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109952703PreviousGS10
00817495024271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07290109952703072901099527037290109952703
00817495024271008174950242718174950242710817495024271

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin contouring systemAn assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007352737customerservice@syneron-candela.com

Regulatory Flags#

DUNS number
053468385
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817495024325Standard 64 Sublative iD, (400 Pulse), 10-PkKT72951KT729512023-10-20
00817495025070Refurbished Applicator 1550 FIN1012082025-05-20
00817495025087Refurbished Applicator 1940FIN1012072025-05-20
00817495024622Glace SBA1038402025-10-07
00817495025292Glace SBA1038782025-10-07
00817495025308Glace SBA1038892025-10-07
00817495025315Glace SBA1039002025-10-07
00817495025339Glace FIN1029552025-10-07
00817495025346Glace FIN1029562025-10-07
00817495025353Glace FIN1029572025-10-07
00817495025360Glace FIN1044922025-10-07
00817495025377Glace FIN1047562025-10-07
00817495025384Glace FIN1045952025-10-07
00817495025391Glace FIN1045942025-10-07
00817495025407Glace MCN1037982025-10-07
00817495025414Glace FIN1029382025-10-07
00817495025421Glace FIN1029422025-10-07
00817495025438Glace FIN1029542025-10-07
008174950244005-Pk, external hygienic, CO2RE IntimaKT76685KT766852023-10-20
00817495024424Handpiece, external CO2RE IntimaAS90245AS902452023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436186MillenniumAvalign Technologies, Inc.GEI2026-10-08
00190776436544MilleniumAvalign Technologies, Inc.GEI2026-10-08
00190776436599MilleniumAvalign Technologies, Inc.GEI2026-10-08
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-08
00848657078504AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078511AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657078528AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083805AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
00848657083904AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-08
B17731226455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-10-08
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215397Disposable Bipolar Forceps, 9", 0.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215403Disposable Bipolar Forceps, 9", 1.0mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00840096215410Disposable Bipolar Forceps, 9", 1.5mm Straight TipsKATALYST SURGICAL LLCGEI2026-10-07
00190776434328MillenniumAvalign Technologies, Inc.GEI2026-10-06
B382SD134188100Surgical DirectSurgical Direct, Inc.GEI2026-10-06
B382SD13798330Surgical DirectSurgical Direct, Inc.GEI2026-10-06
00190776433284MillenniumAvalign Technologies, Inc.GEI2026-10-05
00848657078467AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657078474AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083782AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083812AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083843AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083874AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657083898AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05
00848657084956AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.GEI2026-10-05