The following data is part of a premarket notification filed by Venus Concept Ltd. with the FDA for Venus Viva Sr Device.
| Device ID | K150161 |
| 510k Number | K150161 |
| Device Name: | Venus Viva SR Device |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Venus Concept Ltd. 4556 N.Hiatus Road Sunrise, FL 33351 |
| Contact | Orit Ron Edoute |
| Correspondent | Tal Bresler-stramer Hogan Lovells US LLP 4556 North Hiatus Road Sunrise, FL 33351 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-23 |
| Decision Date | 2015-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016541540 | K150161 | 000 |
| 07290016540277 | K150161 | 000 |
| 07290016540307 | K150161 | 000 |
| 07290016540314 | K150161 | 000 |
| 07290016540376 | K150161 | 000 |
| 07290016540338 | K150161 | 000 |
| 07290016540345 | K150161 | 000 |
| 07290016540697 | K150161 | 000 |
| 07290016541052 | K150161 | 000 |
| 07290016541069 | K150161 | 000 |
| 07290016541076 | K150161 | 000 |
| 07290016541083 | K150161 | 000 |
| 07290016541090 | K150161 | 000 |
| 07290016541106 | K150161 | 000 |
| 07290016540703 | K150161 | 000 |