The following data is part of a premarket notification filed by Solta Medical with the FDA for Thermage Flx System And Accessories.
| Device ID | K170758 |
| 510k Number | K170758 |
| Device Name: | Thermage FLX System And Accessories |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Solta Medical 11720 North Creek Pkwy N., Suite 100 Bothell, WA 98011 |
| Contact | Melissa Thomas |
| Correspondent | Melissa Thomas Melissa Thomas 1400 North Goodman Street Rochester, NY 14609 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-13 |
| Decision Date | 2017-09-22 |
| Summary: | summary |