Identity
- Trade Name
- V10 Console FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Device Name
- V10 Console FDA UDI
- Model / Reference
- VRF2000 FDA UDI
- Description
- V10 Console FDA UDI
Identifiers
- Catalog Number
- VRF2000 FDA UDI
- Primary DI / UDI-DI
- 07290016746020 FDA UDI
- 510(k) Number
- K150035 FDA UDI
- FDA Product Code
- ISA FDA UDIPBX FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 FDA UDI878.4400 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 surface treatment system
V10 Console by Viora Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin surface treatment system.
- Sterile Micro Needle Cartridge — shenb Co., Ltd. · Class II
- MiniFX — Inmode MD , Ltd. · Class II
- Venus Viva GLB package — Venus Concept Inc. · Class II
- Nutritone — Isomers Laboratories, Inc. · Class II
- POLLOGEN LEGEND — POLLOGEN LTD · Class II
- Venus Freeze kit — Venus Concept Inc. · Class II
- INFINI — Lutronic Corporation · Class II
- VIVACE Electrosurgical System — shenb Co., Ltd. · Class II
Cleared under the same submission
K150035 also covers:
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Viora Ltd
Sources (1)
- FDA UDI bab4afb5-e1b4-447f-91c7-4288b5c00697 36 fields · synced Jun 8, 2026