The following data is part of a premarket notification filed by Viora Ltd. with the FDA for V30 System, V-form Handpiece Bc Medium Applicator.
| Device ID | K162363 |
| 510k Number | K162363 |
| Device Name: | V30 System, V-Form Handpiece BC Medium Applicator |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Viora Ltd. 6 Hagavish Street Netanya, IL 4250706 |
| Contact | Stella Raizelman Perry |
| Correspondent | Stella Raizelman Perry Viora Ltd. 6 Hagavish Street Netanya, IL 4250706 |
| 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 | 2016-08-23 |
| Decision Date | 2016-11-18 |
| Summary: | summary |