Legend X Platform
510(k) K252576
Legend X Platform is a Class II device made by Pollogen Ltd, cleared under FDA 510(k) K252576 on 12 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 | NumberK252576 | Date12 Sep 2025 | StatusActive |
Official records
- FDA 510(k) database K252576
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEI
- 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 K252576
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 | |||
|---|---|---|---|---|
| Applicator 2 20900350BK | 20900350BK | 07290016586787 | — | On the market |
| Applicator VO 20900370BK | 20900370BK | 07290016586572 | — | On the market |
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