Identity
- Trade Name
- Viva tip FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Device Name
- Viva applicator disposable tip for single use. FDA UDI
- Model / Reference
- AS110020 FDA UDI
- Description
- Viva applicator disposable tip for single use. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016540338 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin contouring system applicator tip 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dry Heat Sterilization FDA UDI
Category: Radio-frequency skin contouring system applicator tip
Viva tip by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin contouring system applicator tip.
- triFX — POLLOGEN LTD · Class II
- triFX — POLLOGEN LTD · Class II
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- Morpheus8 — Inmode MD , Ltd. · Class II
- VOLNEWMER F tip(D) — CLASSYS Inc. · Class II
- VOLNEWMER S tip — CLASSYS Inc. · Class II
- Morpheus8 Prime 12 pin TIP — Inmode MD , Ltd. · Class II
- triFX — POLLOGEN LTD · Class II
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 applicator — Venus Concept Inc.
- Venus Viva kit — 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 applicator — Venus Concept Inc.
- Venus Viva kit — 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 b89a8fa3-2282-448b-8ff4-d5305f132a7e 34 fields · synced Jun 1, 2026