OptiLUV Device
by Pollogen Ltd
510(k) K250734
OptiLUV Device is a Class II device made by Pollogen Ltd, cleared under FDA 510(k) K250734 on 10 Sep 2025, 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 | FDA 510(k)SESE | NumberK250734 | Date10 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K250734
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PBX
- FDA applicant
- Pollogen, Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K250734
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| OptiLUV | 3466300WT-US / OptiLUV | 07290016586732 | — | On the market |
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