The following data is part of a premarket notification filed by Venus Concept Ltd. with the FDA for Venus Versa System.
| Device ID | K153717 |
| 510k Number | K153717 |
| 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 Floor 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 | 2015-12-24 |
| Decision Date | 2016-03-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016541205 | K153717 | 000 |
| 27290016541216 | K153717 | 000 |
| 27290016541223 | K153717 | 000 |
| 07290016540505 | K153717 | 000 |
| 07290016540406 | K153717 | 000 |
| 07290016540413 | K153717 | 000 |
| 07290016540536 | K153717 | 000 |
| 07290016540543 | K153717 | 000 |
| 07290016540444 | K153717 | 000 |
| 07290016540567 | K153717 | 000 |
| 07290016540468 | K153717 | 000 |
| 07290016540475 | K153717 | 000 |
| 07290016540482 | K153717 | 000 |
| 07290016540598 | K153717 | 000 |
| 07290016541168 | K153717 | 000 |
| 07290016541182 | K153717 | 000 |
| 07290016541199 | K153717 | 000 |
| 27290016541179 | K153717 | 000 |