FDA.reportPublic FDA data

V-FC Pro Full

Primary DI
07290016746785
Brand
V-FC Pro Full
Company
VIORA LTD
Model
VTL48015-F
Catalog number
VTL48015-F
Device description
Kit of V-FC Pro Handpiece, V-FC Pro Tips and maintenance kit
Published
2025-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PBXMassager, Vacuum, Radio Frequency Induced Heat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200468000V30 system, V20 system, V10 system, V-FC HandpieceViora , Ltd.2020-05-21PBX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016746785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016746785072900167467857290016746785

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemAn electrically-powered assembly of devices intended to use multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, radio-frequency (RF) energy, microcurrent electrotherapy, electronic muscle stimulation (EMS), microdermabrasion, hydradermabrasion, oxygen skin application] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes energy/therapy sources (e.g., lasers, lamps, generator) and dedicated applicators (handpieces) intended to apply the different therapies to the skin.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888 415 1192CustomerCareUsa@sinclair.com

Regulatory Flags#

DUNS number
514612758
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016746044V-IPL HP BasicVTL43000VTL430002016-09-23
07290016746051V-IPL HP FullVTL43040VTL430402016-09-23
07290016746068V-IPL HP FullVTL43060VTL430602016-09-23
07290016746402V-FR HandpieceV-FR20022026-04-19
07290016746501V-FR TipVTO20022026-04-19
07290016746563V-IPL Optic set Full 6 filtersVTL43050-6VTL43050-62025-12-22
07290016746662V-FC TipVTL48014VTL480142025-05-22
07290016746433ST Single Use TipAS47010AS470102025-06-03
07290016746457V-ST Single Use tipAS47000AS470002025-06-03
07290016746754Treatment Kit 2.0GM00030 (US)GM00030 (US)2025-06-03
07290016746464V-ST Single Use tipAS47000AS470002025-06-03
07290016746471V-VR HandpieceVTL48010VTL480102025-06-03
17290016746652V-FC TipAS70028AS700282025-05-22
07290016746808V-FC Pro TipVTL48018VTL480182025-09-01
07290016746815V-FC Pro HandpieceVTL48017VTL480172025-09-01
07290016746716ConsoleMM40000-USMM40000-US2025-05-22
07290016746723ApplicatorMM01000-USMM01000-US2025-05-22
07290016746730TrolleyMM60000-USMM60000-US2025-05-22
07290016746747Disposable Delivery NozzleMM05000-2.0 (US)MM05000-2.0 (US)2025-05-22
07290016746495DermaFuseDER0110DER01102025-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974223650141WinForthShenzhen Leaflife Technology Co., Ltd.PBX2026-04-22
07290016746402V-FR HandpieceVIORA LTDPBX2026-04-19
07290016746501V-FR TipVIORA LTDPBX2026-04-19
00810060832851Venus NovaVenus Concept Inc.PBX2026-04-15
00850055552494BellaTform ApplicatorInbella Medical IncPBX2026-04-02
00850055552180BellaPlus90 ApplicatorInbella Medical IncPBX2026-03-30
00850055552715i-BellaForma ApplicatorInbella Medical IncPBX2026-03-30
00850055552005BellaBodyFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552036BellaForma ApplicatorInbella Medical IncPBX2026-03-26
00850055552043BellaPlus ApplicatorInbella Medical IncPBX2026-03-26
00850055552067BellaMiniFX ApplicatorInbella Medical IncPBX2026-03-26
00850055552470InBellaBody SystemInbella Medical IncPBX2026-03-25
00850055552555InBellaMax SystemInbella Medical IncPBX2026-03-25
08056182720634SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721143SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721167SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721174SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721181SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721198SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721204SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721211SUPERCHARGE HYDRA FASCIA ELECTRODESUNIBELL SRLPBX2026-03-16
08056182721327SUPERCHARGE HYDRA FASCIA ELECTRODES UNIBELL SRLPBX2026-03-16
08800092098013D20-RF0BDaeyang Medical Co., Ltd.PBX2026-03-10
04053915986880Tecarpuls IIZimmer MedizinSysteme GmbHPBX2026-02-12
07290016746563V-IPL Optic set Full 6 filtersVIORA LTDPBX2025-12-22
07290016814569PRO MAX, System, 110VENDYMED MEDICAL LTDPBX2025-11-17
08034108513270ONDA PRODEKA M.E.L.A. SRLPBX2025-11-17
08034108513263body ESTIQDEKA M.E.L.A. SRLPBX2025-09-26
07290016746808V-FC Pro TipVIORA LTDPBX2025-09-01
07290016746815V-FC Pro HandpieceVIORA LTDPBX2025-09-01