FDA.reportPublic FDA data

Repl. Cover

Primary DI
07290109950358
Brand
Repl. Cover
Company
SYNERON MEDICAL LTD
Model
AS74672
Catalog number
AS74672
Device description
Repl. Cover (Grey), SA-1Hr, VelaShape II
Published
2016-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K071872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071872000VELASHAPESyneron Medical, Ltd.2007-08-22NUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290109950358PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109950358072901099503587290109950358

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532685716
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109952697SA Med. Repl. Cover 25x30mm, 4Hr, Velashape IIIAS83333AS833332017-06-01
07290109952703SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III AS87512AS875122017-06-01
17290109950416SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape IIIKT75061KT750612016-09-26
17290109950423SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape IIIKT75671KT756712016-09-26
17290109950430SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape IIIKT75071KT750712016-09-26
17290109952151LA Repl. Stacking Covers 8 Hr 5PkKT74831KT748312016-09-26
17290109952212LA Replaceable Cover (4 Hr) 5-PkKT75102KT751022016-09-26
37290109950342LA Repl. Cvr. (1Hr) 10-PkKT71745KT717452016-09-26
37290109950359SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II KT71751KT717512016-09-26
37290109950410SA Repl. Small Cvr. 10x13mm (4 Hr) 10-Pk, Velashape IIIKT7425AKT7425A2016-09-26
37290109950427SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 10-Pk, Velashape IIIKT75661KT756612016-09-26
37290109950434SA Repl. Med. Cvr. 25x30mm (4 Hr) 10-Pk, Velashape IIIKT7426AKT7426A2016-09-26
37290109952162LA Repl. Stacking Covers (16 Hr) 10-PkKT74841KT748412016-09-26
07290109950242VelaShape systemFG00131FG001312016-09-20
07290109950259Vsmooth ApplicatorFG00101FG001012016-09-20
07290109950266Vcontour Applicator FG00111FG001112016-09-20
07290109950303Vela Shape II systemFG70321FG703212016-09-20
07290109950310Vela Shape II systemFG70331FG703312016-09-20
07290109950327Vsmooth ApplicatorFG70341FG703412016-09-20
07290109950334Vcontour ApplicatorFG70351FG703512016-09-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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