The following data is part of a premarket notification filed by Thermage, Inc. with the FDA for Modification To Thermage Thermacool System.
| Device ID | K053365 |
| 510k Number | K053365 |
| Device Name: | MODIFICATION TO THERMAGE THERMACOOL SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | THERMAGE, INC. 25881 INDUSTRIAL BLVD. Hayward, CA 94545 |
| Contact | Pamela M Buckman |
| Correspondent | Pamela M Buckman THERMAGE, INC. 25881 INDUSTRIAL BLVD. Hayward, CA 94545 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-02 |
| Decision Date | 2005-12-13 |
| Summary: | summary |