The following data is part of a premarket notification filed by Viveve, Inc. with the FDA for Viveve 2.0 System.
| Device ID | K213814 |
| 510k Number | K213814 |
| Device Name: | Viveve 2.0 System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Viveve, Inc. 345 Inverness Drive South, Building B, Suite 250 Englewood, CO 80112 |
| Contact | Kevin Robison |
| Correspondent | Kevin Robison Viveve, Inc. 345 Inverness Drive South, Building B, Suite 250 Englewood, CO 80112 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-07 |
| Decision Date | 2022-02-02 |