STOP U Model UXV Device
FDA 510(k) clearance K203665 · decided 2021-02-25
Clearance details
- K-number
- K203665
- Device name
- STOP U Model UXV Device
- Applicant
- Pollogen, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-12-16
- Decision date
- 2021-02-25
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- PAY
- Device class
- 2
- Regulation number
- 878.4420
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Tel Aviv, IL
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| Sensilift Pro (ST300XXYYZZZ) (K250341) | El Global Trade, Ltd. | 2026-01-06 |
| GENEO X ELITE (K242227) | Pollogen, Ltd. | 2025-10-12 |
| FAQ™ (102) (K240616) | Foreo, Inc. | 2024-07-15 |
| Geneo X Elite (K233766) | Pollogen, Ltd. | 2024-05-07 |
| CurrentBody Skin RF (K232424) | El Global Trade, Ltd. | 2024-03-06 |
| Silk'n Titan Allways (K230013) | Silk'N Beauty , Ltd. | 2023-08-30 |
| Pollogen STOP U Model UXV Device (K220322) | Pollogen, Ltd. | 2023-05-04 |
| FAQ 101 (K222012) | Foreo, Inc. | 2023-04-05 |
| STOP U (Packed Black USA), STOP U (Packed White USA) (K182774) | Pollogen, Ltd. | 2019-06-19 |
| sensiLift (K170499) | El Global Trade, Ltd. | 2017-06-15 |
| Newa Skin Therapy System (DEN150005) | Endymed Medical, Ltd. | 2015-12-18 |
Recalls involving this device
No recalls on record reference this clearance.