Identity
- Trade Name
- STOP VX GOLD MODEL U FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Model / Reference
- STOP U MODEL UXV FDA UDI
Identifiers
- Catalog Number
- 34650000GL-US FDA UDI
- Primary DI / UDI-DI
- 07290016586466 FDA UDI
- 510(k) Number
- K203665 FDA UDI
- FDA Product Code
- PAY FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4420 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
Yes
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: Multi-modality skin/body contouring system
Stop Vx Gold Model U by Pollogen Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K203665 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pollogen Ltd
Sources (1)
- FDA UDI a20ca885-7dd5-4d39-befd-cf6085e501be 34 fields · synced Jun 8, 2026