Identity
- Trade Name
- V-ST HP FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator, bipolar FDA UDI
- Device Name
- V-ST HP FDA UDI
- Model / Reference
- V-ST2001 FDA UDI
- Description
- V-ST HP FDA UDI
Identifiers
- Catalog Number
- V-ST2001 FDA UDI
- Primary DI / UDI-DI
- 07290016746280 FDA UDI
- FDA Product Code
- PBX FDA UDI
- GMDN Term
- Radio-frequency skin contouring system applicator, bipolar FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin contouring system applicator, bipolar
V-St Hp by Viora Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radio-frequency skin contouring system applicator, bipolar.
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- Venus Viva applicator — Venus Concept Inc. · Class II
Cleared under the same submission
K133837 also covers:
- V- IPL Handpiece — VIORA LTD
- V-IPL Filter AC-415 — VIORA LTD
- V-IPL Filter HR-570 — VIORA LTD
- V-IPL Filter HR-630 — VIORA LTD
- V-IPL Filter HR-755 — VIORA LTD
- V-IPL Filter SR-580 — VIORA LTD
- V-IPL Filter VP-530 — VIORA LTD
- V-IPL HP Basic — VIORA LTD
- V-IPL HP Extended — VIORA LTD
- V-IPL HP Full — VIORA LTD
- V-IPL Optic set Basic — VIORA LTD
- V-IPL Optic set Extended — VIORA LTD
K142093 also covers:
- V- IPL Handpiece — VIORA LTD
- V-IPL Filter AC-415 — VIORA LTD
- V-IPL Filter HR-570 — VIORA LTD
- V-IPL Filter HR-630 — VIORA LTD
- V-IPL Filter HR-755 — VIORA LTD
- V-IPL Filter SR-580 — VIORA LTD
- V-IPL Filter VP-530 — VIORA LTD
- V-IPL HP Basic — VIORA LTD
- V-IPL HP Extended — VIORA LTD
- V-IPL HP Full — VIORA LTD
- V-IPL Optic set Basic — VIORA LTD
- V-IPL Optic set Extended — VIORA LTD
K150035 also covers:
K152611 also covers:
- BC Large Applicator — VIORA LTD
- BC Medium Applicator — VIORA LTD
- BC Small Applicator — VIORA LTD
- V- IPL Handpiece — VIORA LTD
- V-FORM — VIORA LTD
- V-IPL Filter AC-415 — VIORA LTD
- V-IPL Filter HR-570 — VIORA LTD
- V-IPL Filter HR-630 — VIORA LTD
- V-IPL Filter HR-755 — VIORA LTD
- V-IPL Filter SR-580 — VIORA LTD
- V-IPL Filter VP-530 — VIORA LTD
- V-IPL HP Basic — VIORA LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Viora Ltd
Sources (1)
- FDA UDI f8c54965-0fbe-4bd0-874f-5db7db552228 36 fields · synced May 30, 2026