The following data is part of a premarket notification filed by Viora Ltd. with the FDA for V30 System, V20 System, V10 System, V-fc Handpiece.
| Device ID | K200468 |
| 510k Number | K200468 |
| Device Name: | V30 System, V20 System, V10 System, V-FC Handpiece |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Viora Ltd. 6 Hagavish Street Netanya, IL 4250706 |
| Contact | Simona Forman Krant |
| Correspondent | Simona Forman Krant Viora Ltd. 6 Hagavish Street Netanya, IL 4250706 |
| Product Code | PBX |
| Subsequent Product Code | GEX |
| Subsequent Product Code | ISA |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-26 |
| Decision Date | 2020-05-21 |