FDA.reportPublic FDA data

SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III

Primary DI
00817495024462
Brand
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
Company
Candela Corporation
Model
AS83333
Device description
SA Med. Repl. Cover 25x30mm, 4Hr, 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

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
00817495024462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817495024462008174950244628174950244620817495024462

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

Regulatory Flags#

DUNS number
053468385
Device count
1
Lot or batch
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
00817495022727Vcontour applicatorCandela 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