The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Venus Bliss.
| Device ID | K190743 |
| 510k Number | K190743 |
| Device Name: | Venus Bliss |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 |
| Contact | Yoni Iger |
| Correspondent | Elissa Burg BioVision Ltd Had Nes 183 Had Nes, IL 1295000 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-22 |
| Decision Date | 2019-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016541724 | K190743 | 000 |
| 07290016541717 | K190743 | 000 |
| 07290016541625 | K190743 | 000 |
| 07290016541618 | K190743 | 000 |
| 07290016541564 | K190743 | 000 |
| 07290016541632 | K190743 | 000 |
| 00810060830444 | K190743 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VENUS BLISS 88584367 not registered Live/Pending |
Venus Concept USA Inc. 2019-08-19 |
![]() VENUS BLISS 88584360 not registered Live/Pending |
Venus Concept USA Inc. 2019-08-19 |