The following data is part of a premarket notification filed by Venus Concept Ltd. with the FDA for Venus Legacy Cx.
| Device ID | K143554 |
| 510k Number | K143554 |
| Device Name: | Venus Legacy CX |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Venus Concept Ltd. 4556 N.Hiatus Road Sunrise, FL 33351 |
| Contact | Orit Ron Edoute |
| Correspondent | Tal Bresler-stramer Hogan Lovells US LLP 4556 Hiatus Road Sunrise, FL 33351 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-15 |
| Decision Date | 2015-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016541144 | K143554 | 000 |
| 00810060830833 | K143554 | 000 |
| 00810060830840 | K143554 | 000 |
| 07290016540000 | K143554 | 000 |
| 07290016540017 | K143554 | 000 |
| 07290016540024 | K143554 | 000 |
| 07290016540031 | K143554 | 000 |
| 07290016540048 | K143554 | 000 |
| 07290016540055 | K143554 | 000 |
| 07290016540062 | K143554 | 000 |
| 07290016540079 | K143554 | 000 |
| 07290016540109 | K143554 | 000 |
| 07290016540116 | K143554 | 000 |
| 07290016541137 | K143554 | 000 |
| 00810060830826 | K143554 | 000 |