FDA records / RF skin devices
RF skin devices: FDA records
All loaded records in the verified product-code scope. Some refer to professional devices or discontinued models. Inclusion does not establish home use or match a retail product.
11 records
SESE: substantially equivalent 510(k) decision.
| Device name | Applicant | Record | Code | Decision date | Decision |
|---|---|---|---|---|---|
| Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | K250341 | PAY | 2026-01-06 | SESE |
| GENEO X ELITE | Pollogen, Ltd. | K242227 | PAY | 2025-10-12 | SESE |
| FAQ (102) | Foreo, Inc. | K240616 | PAY | 2024-07-15 | SESE |
| Geneo X Elite | Pollogen, Ltd. | K233766 | PAY | 2024-05-07 | SESE |
| CurrentBody Skin RF | El Global Trade, Ltd. | K232424 | PAY | 2024-03-06 | SESE |
| Silk'n Titan Allways | Silk'N Beauty , Ltd. | K230013 | PAY | 2023-08-30 | SESE |
| Pollogen STOP U Model UXV Device | Pollogen, Ltd. | K220322 | PAY | 2023-05-04 | SESE |
| FAQ 101 | Foreo, Inc. | K222012 | PAY | 2023-04-05 | SESE |
| STOP U Model UXV Device | Pollogen, Ltd. | K203665 | PAY | 2021-02-25 | SESE |
| STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | K182774 | PAY | 2019-06-19 | SESE |
| sensiLift | El Global Trade, Ltd. | K170499 | PAY | 2017-06-15 | SESE |