The following data is part of a premarket notification filed by Viveve Medical with the FDA for Viveve System 2.0.
| Device ID | K190422 |
| 510k Number | K190422 |
| Device Name: | Viveve System 2.0 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Viveve Medical 345 Inverness Drive South, Building B, Suite 250 Englewood, CO 80109 |
| Contact | Suzon Lommel |
| Correspondent | Suzon Lommel Viveve Medical 345 Inverness Drive South, Building B, Suite 250 Englewood, CO 80109 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-06-12 |