The following data is part of a premarket notification filed by Thermi with the FDA for Thermi Injectable Rf Electrodes.
| Device ID | K170116 |
| 510k Number | K170116 |
| Device Name: | Thermi Injectable RF Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Thermi 8304 Esters Boulevard Irving, TX 75063 |
| Contact | Suzanne Cheang |
| Correspondent | Suzanne Cheang Thermi 8304 Esters Boulevard 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 | 2017-01-13 |
| Decision Date | 2017-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817371020298 | K170116 | 000 |
| 00817771029204 | K170116 | 000 |
| 00817771029211 | K170116 | 000 |
| 00817771029228 | K170116 | 000 |
| 00817771029235 | K170116 | 000 |
| 00817771029242 | K170116 | 000 |
| 00817771029259 | K170116 | 000 |
| 00817771029266 | K170116 | 000 |
| 00817371020113 | K170116 | 000 |
| 00817371020212 | K170116 | 000 |
| 00817371020229 | K170116 | 000 |
| 00817371020236 | K170116 | 000 |
| 00817371020243 | K170116 | 000 |
| 00817771029198 | K170116 | 000 |