The following data is part of a premarket notification filed by Venus Concept Usa Inc. with the FDA for Venus Blissmax.
| Device ID | K220592 |
| 510k Number | K220592 |
| Device Name: | Venus BlissMAX |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 |
| Contact | William H. Mcgrail |
| Correspondent | William H. Mcgrail Venus Concept USA Inc. 1880 N Commerce Pkwy, Suite 2 Weston, FL 33326 |
| Product Code | PBX |
| Subsequent Product Code | NGX |
| Subsequent Product Code | PKT |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-04-27 |