The following data is part of a premarket notification filed by Pollogen Ltd. with the FDA for Stop U Model Uxv Device.
| Device ID | K203665 |
| 510k Number | K203665 |
| Device Name: | STOP U Model UXV Device |
| Classification | Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Applicant | Pollogen Ltd. 6 Kaufman St. Tel Aviv, IL 6801298 |
| Contact | Ayala Kamil |
| Correspondent | Elissa Burg BioVision Ltd. Had Nes 183 Had Nes, IL 1295000 |
| Product Code | PAY |
| CFR Regulation Number | 878.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-16 |
| Decision Date | 2021-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016586442 | K203665 | 000 |
| 07290016586466 | K203665 | 000 |
| 07290016586626 | K203665 | 000 |
| 07290016586459 | K203665 | 000 |