The following data is part of a premarket notification filed by Thermgen, L.l.c with the FDA for Thermi Reusable Non-invasive Rf Electrode.
| Device ID | K171094 |
| 510k Number | K171094 |
| Device Name: | Thermi Reusable Non-invasive RF Electrode |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ThermGen, L.L.C 8304 Esters Boulevard Suite 890 Irving, TX 75063 |
| Contact | Suzanne Cheang |
| Correspondent | Suzanne Cheang ThermGen, L.L.C 8304 Esters Boulevard Suite 890 Irving, TX 75063 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-12 |
| Decision Date | 2017-05-08 |
| Summary: | summary |