The following data is part of a premarket notification filed by Venus Concept Ltd. with the FDA for Venus Versa System.
| Device ID | K152790 |
| 510k Number | K152790 |
| Device Name: | Venus Versa System |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | VENUS CONCEPT LTD. 4556 N. HIATUS ROAD Sunrise, FL 33351 |
| Contact | Tal Bresler-stramer |
| Correspondent | Janice Hogan HOGAN LOVELLS US LLP 1835 MARKET STREET., 29TH FL Philadelphia, PA 19103 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-25 |
| Decision Date | 2016-01-20 |
| Summary: | summary |