The following data is part of a premarket notification filed by Pollogen Ltd. with the FDA for Stop U (packed Black Usa), Stop U (packed White Usa).
| Device ID | K182774 |
| 510k Number | K182774 |
| Device Name: | STOP U (Packed Black USA), STOP U (Packed White USA) |
| Classification | Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Applicant | Pollogen Ltd. 6 Kaufman St. Tel Aviv, IL 6801298 |
| Contact | Einat Shammai |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-01 |
| Decision Date | 2019-06-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290018007303 | K182774 | 000 |
| 07290018007686 | K182774 | 000 |