The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Family Of Venus Rf Systems - Venus Freedom.
| Device ID | K211461 |
| 510k Number | K211461 |
| Device Name: | Family Of Venus RF Systems - Venus Freedom |
| 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 | Yoni Iger Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-11 |
| Decision Date | 2021-10-14 |