OptiLUV
by Pollogen Ltd
OptiLUV (3466300WT-US) is a Class II device made by Pollogen Ltd, cleared under FDA 510(k) K250734 on 10 Sep 2025 and listed in FDA GUDID since 21 Jun 2026 (UDI-DI 07290016586732), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07290016586732 | Date21 Jun 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK250734 | Date10 Sep 2025 | StatusActive |
Official records
- AccessGUDID record 07290016586732
- FDA 510(k) database K250734
Across registries
- FDA 510(k) K250734 decided 10 Sep 2025 Active
- FDA GUDID UDI-DI 07290016586732 listed 21 Jun 2026 Listed
Timeline
- Cleared FDA 510(k) K250734
- Listed FDA GUDID 07290016586732
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Multi-modality skin/body contouring system
- Model / Ref / Catalog
- OptiLUV, 3466300WT-US
- Primary DI / UDI-DI
- 07290016586732
- 510(k) Number
- FDA product code
- PBX, GEI
- GMDN term
- Multi-modality skin/body contouring system
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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