The following data is part of a premarket notification filed by Vydence with the FDA for Siberian Fit.
| Device ID | K172439 |
| 510k Number | K172439 |
| Device Name: | Siberian Fit |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Vydence Rua Aldo Germano Klein, 359 Cep: 13.573-470 - Caixa Postal 772 Sao Carlos/ Sp Sao Paulo, BR 13.573-470 |
| Contact | Kevin Walls |
| Correspondent | Kathy Maynor Kathy Maynor 26 Rebecca Ct Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-11 |
| Decision Date | 2018-02-14 |