Identity
- Trade Name
- Venus Viva applicator FDA UDI
- Generic Name
- Radio-frequency skin surface treatment system FDA UDI
- Model / Reference
- AS112011 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016540260 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin surface treatment system 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
No
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin surface treatment system
Venus Viva applicator by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K150161 also covers:
- Diamond applicator — Venus Concept Inc.
- Venus Vila GLB system — Venus Concept Inc.
- Venus Viva — Venus Concept Inc.
- Venus Viva - Diamondpolar applicator — Venus Concept Inc.
- Venus Viva GLB Diamondpolar applicator — Venus Concept Inc.
- Venus Viva GLB Diamondpolar applicator spare parts package — Venus Concept Inc.
- Venus Viva GLB applicator — Venus Concept Inc.
- Venus Viva GLB applicator spare parts package — Venus Concept Inc.
- Venus Viva GLB package — Venus Concept Inc.
- Venus Viva applicator — Venus Concept Inc.
- Venus Viva kit — Venus Concept Inc.
- Venus Viva kit package — Venus Concept Inc.
K191065 also covers:
- Diamond applicator — Venus Concept Inc.
- Venus Vila GLB system — Venus Concept Inc.
- Venus Viva — Venus Concept Inc.
- Venus Viva - Diamondpolar applicator — Venus Concept Inc.
- Venus Viva GLB Diamondpolar applicator — Venus Concept Inc.
- Venus Viva GLB Diamondpolar applicator spare parts package — Venus Concept Inc.
- Venus Viva GLB applicator — Venus Concept Inc.
- Venus Viva GLB applicator spare parts package — Venus Concept Inc.
- Venus Viva GLB package — Venus Concept Inc.
- Venus Viva applicator — Venus Concept Inc.
- Venus Viva kit — Venus Concept Inc.
- Venus Viva kit package — Venus Concept Inc.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Venus Concept Inc.
Sources (1)
- FDA UDI 1e3584b8-5652-4198-b5a1-b1bc33cbad46 33 fields · synced May 30, 2026