FDA.reportPublic FDA data

Vcontour applicator

Primary DI
00817495022727
Brand
Vcontour applicator
Company
Candela Corporation
Model
FG71012
Catalog number
FG71012
Device description
Vcontour Applicator, Velashape III
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
NUVMassager, Vacuum, Light Induced Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122579000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122579000VELASHAPESyneron Medical, Ltd.2012-09-13NUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109950396PreviousGS10
00817495022727PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
07290109950396072901099503967290109950396
00817495022727008174950227278174950227270817495022727

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
800-735-2737customerservice@syneron-candela.com

Regulatory Flags#

DUNS number
053468385
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00817495024431Purple Swivel Lens CO2REAS90411AS904112023-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019863359ApexRF ApplicatorINMODE M.D LTDNUV2025-06-04
07290016746433ST Single Use TipVIORA LTDNUV2025-06-03
08053782383283T-SHAPE 2B&M SRL MARKETING NEL BENESSERENUV2025-04-11
07290019863342APEX RF SystemINMODE M.D LTDNUV2025-01-09
07290016633573Define SystemINMODE M.D LTDNUV2025-01-07
07290016633726Envision SystemINMODE M.D LTDNUV2024-03-24
07290019863311InMode OPINMODE M.D LTDNUV2024-03-24
07290019863014CelluTite SystemINMODE M.D LTDNUV2024-03-19
18057592610246icoone Laser HealthcareI-TECH INDUSTRIES SRLNUV2023-11-30
18057592610277Icoone Laser MedI-TECH INDUSTRIES SRLNUV2023-11-30
18057592610307Icoone LaserI-TECH INDUSTRIES SRLNUV2023-11-30
18057592610369Icoone Laser BodyI-TECH INDUSTRIES SRLNUV2023-11-30
00817495024462SA Med. Repl. Cover 25x30mm, 4Hr, Velashape IIICandela CorporationNUV2023-10-20
00817495024578SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape IIICandela CorporationNUV2023-10-20
07290110122317Accent Prime System 120V For Inc.ALMA LASERS LTD.NUV2022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.ALMA LASERS LTD.NUV2022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.ALMA LASERS LTD.NUV2022-11-22
07290110122348Accent Prime Ultra Applicator for Inc.ALMA LASERS LTD.NUV2022-11-22
07290016633702EmPowerRF platformINMODE M.D LTDNUV2022-10-25
07290016633658FormaIINMODE M.D LTDNUV2022-01-05
17290110122154Opus Colibri 0.7mm Single-use Tip Set (X6)ALMA LASERS LTD.NUV2021-11-14
17290110122161Opus Colibri 1mm Single-use Tip Set (X6)ALMA LASERS LTD.NUV2021-11-14
17290110122178Opus Colibri 0.7mm Single-use Tip (X1)ALMA LASERS LTD.NUV2021-11-14
17290110122185Opus Colibri 1mm Single-use Tip (X1)ALMA LASERS LTD.NUV2021-11-14
17290110122192Glide Disposable Tip (x1)ALMA LASERS LTD.NUV2021-11-14
17290110122208Glide Disposable Tip Set (X12)ALMA LASERS LTD.NUV2021-11-14
17290110122086Opus Plasma ApplicatorALMA LASERS LTD.NUV2021-01-25
17290110121782Opus System 110V ALMA LASERS LTD.NUV2020-02-20
17290110121805Opus Plasma HP/ApplicatorALMA LASERS LTD.NUV2020-02-17
17290110121768Accent Elite System 110V (Black)ALMA LASERS LTD.NUV2019-12-31