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 |