The following data is part of a premarket notification filed by Viora Ltd. with the FDA for V20 System.
| Device ID | K152611 |
| 510k Number | K152611 |
| Device Name: | V20 System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | VIORA LTD. 3 MASKIT STREET Herzliya, IL 4673303 |
| Contact | Omri Kesler |
| Correspondent | Omri Kesler VIORA LTD. 3 MASKIT STREET Herzliya, IL 4673303 |
| Product Code | GEX |
| Subsequent Product Code | ISA |
| Subsequent Product Code | PBX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-14 |
| Decision Date | 2016-02-19 |
| Summary: | summary |