The following data is part of a premarket notification filed by Viora Ltd. with the FDA for Viora V-touch.
| Device ID | K141904 |
| 510k Number | K141904 |
| Device Name: | VIORA V-TOUCH |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | VIORA LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy VIORA LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-14 |
| Decision Date | 2014-10-21 |
| Summary: | summary |