The following data is part of a premarket notification filed by Vydence Medical Industria E Comercio Ltda with the FDA for Vydence Laser Family.
| Device ID | K190007 |
| 510k Number | K190007 |
| Device Name: | Vydence Laser Family |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Vydence Medical Industria E Comercio Ltda Rua Aldo Germano Klein, 359 Cep: 13.573-470 - Caixa Postal 772 Ceat - Sao Carlos, BR 13.573-470 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor Vydence Medical 26 Rebecca Ct. Homosassa, FL 34446 |
| Product Code | GEX |
| Subsequent Product Code | ONF |
| Subsequent Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-02 |
| Decision Date | 2019-03-01 |