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 |