The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Venus Viva Md Device.
| Device ID | K201164 |
| 510k Number | K201164 |
| Device Name: | Venus Viva MD Device |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 |
| Contact | Yoni Iger |
| Correspondent | Yoni Iger Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-06-26 |