V-FC Tip AS70028

GUDID 17290016746652

V-FC Tip

VIORA LTD

Multi-modality skin surface treatment system
Primary Device ID17290016746652
NIH Device Record Key938643c3-0066-405b-9a21-fb6f982a0c10
Commercial Distribution StatusIn Commercial Distribution
Brand NameV-FC Tip
Version Model NumberAS70028
Catalog NumberAS70028
Company DUNS514612758
Company NameVIORA LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com
Phone888 415 1192
EmailCustomerCareUsa@sinclair.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016746662 [Primary]
GS117290016746652 [Package]
Contains: 07290016746662
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBXMassager, Vacuum, Radio Frequency Induced Heat

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2025-09-09
Device Publish Date2025-05-22

Devices Manufactured by VIORA LTD

07290016746464 - V-ST Single Use tip2025-09-09 V-ST Single Use tip
07290016746471 - V-VR Handpiece2025-09-09 V-VR Handpiece
17290016746652 - V-FC Tip2025-09-09V-FC Tip
17290016746652 - V-FC Tip2025-09-09 V-FC Tip
07290016746785 - V-FC Pro Full2025-09-09 Kit of V-FC Pro Handpiece, V-FC Pro Tips and maintenance kit
07290016746808 - V-FC Pro Tip2025-09-09
07290016746815 - V-FC Pro Handpiece2025-09-09
07290016746716 - Console2025-07-31 EnerJet Console
07290016746723 - Applicator2025-07-31 EnerJet Applicator

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