The following data is part of a premarket notification filed by Venus Concept Ltd. with the FDA for Venus Velocity Diode Laser System.
| Device ID | K162765 |
| 510k Number | K162765 |
| Device Name: | Venus Velocity Diode Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Venus Concept Ltd. 4556 N. Hiatus Road Sunrise, FL 33351 |
| Contact | Tal Bresler-stramer |
| Correspondent | Janice Hogan Hogan Lovells US LLP 1835 Market St., 29th Floor Philadelphia, PA 19103 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-30 |
| Decision Date | 2017-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016541359 | K162765 | 000 |
| 07290016540673 | K162765 | 000 |
| 07290016540666 | K162765 | 000 |
| 07290016540659 | K162765 | 000 |
| 07290016540642 | K162765 | 000 |
| 07290016540635 | K162765 | 000 |
| 07290016540628 | K162765 | 000 |
| 00810060830574 | K162765 | 000 |