The following data is part of a premarket notification filed by Solta Medical, Inc. with the FDA for Thermage Cpt System.
| Device ID | K132431 |
| 510k Number | K132431 |
| Device Name: | THERMAGE CPT SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD. Hayward, CA 94545 |
| Contact | Raymond Lee |
| Correspondent | Raymond Lee SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD. Hayward, CA 94545 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-05 |
| Decision Date | 2013-09-06 |
| Summary: | summary |