The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Venus Vivatm.
| Device ID | K191065 |
| 510k Number | K191065 |
| Device Name: | Venus VivaTM |
| 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 | 2019-04-22 |
| Decision Date | 2020-04-01 |