The following data is part of a premarket notification filed by Pollogen Ltd. with the FDA for Yandr System, Voluderm Handpiece, Voluderm Tips.
| Device ID | K220124 |
| 510k Number | K220124 |
| Device Name: | YandR System, VoluDerm Handpiece, VoluDerm Tips |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Pollogen Ltd. 6 Kaufman Street Tel Aviv, IL 6801298 |
| Contact | Sharon Ravid |
| Correspondent | Kathy Maynor Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-18 |
| Decision Date | 2022-02-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810096330055 | K220124 | 000 |