Identity
- Trade Name
- Venus Freeze Plus FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator, bipolar FDA UDI
- Device Name
- The Venus Freeze Plus system is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkle and rhytides in Fitzpatrick skin I-IV FDA UDI
- Model / Reference
- FRP00002 FDA UDI
- Description
- The Venus Freeze Plus system is a non invasive device intended for use in dermatologic and general procedures for females for the non invasive treatment of moderate to severe facial wrinkle and rhytides in Fitzpatrick skin I-IV FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016540222 FDA UDI
- 510(k) Number
- K111670 FDA UDI
- FDA Product Code
- GEI 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
No
FDA UDI
Category: Radio-frequency skin contouring system applicator, bipolar
Venus Freeze Plus 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, bipolar.
- ST — FORMATK SYSTEMS LTD · Class II
- V-ST HP — VIORA LTD · Class II
- LF2 applicator — Venus Concept Inc. · Class II
- Diamondpolar applicator — Venus Concept Inc. · Class II
- LB2 + LF2 kit — Venus Concept Inc. · Class II
- Venus Viva applicator — Venus Concept Inc. · Class II
- Venus Freeze applicators kit — Venus Concept Inc. · Class II
- Octipolar applicator — Venus Concept Inc. · Class II
Cleared under the same submission
K111670 also covers:
- Diamondpolar applicator for Freeze Plus — Venus Concept Inc.
- Diamondpolar applicator for Venus Freeze — Venus Concept Inc.
- Octipoar applicator for Venus Freeze — Venus Concept Inc.
- Octipolar applicator for Venus Freeze — Venus Concept Inc.
- Venus Freeze MP2 — Venus Concept Inc.
- Venus Freeze Plus kit — Venus Concept Inc.
- Venus Freeze applicators kit — Venus Concept Inc.
- Venus Freeze 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 |
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Manufacturer
- Manufacturer
- Venus Concept Inc.
Sources (1)
- FDA UDI d68b2ac5-302e-485e-9701-c82bf757e3ee 34 fields · synced May 30, 2026