The following data is part of a premarket notification filed by Thermage, Inc. with the FDA for Thermage Thermacool Ii System.
| Device ID | K003183 |
| 510k Number | K003183 |
| Device Name: | THERMAGE THERMACOOL II SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | THERMAGE, INC. 4058 POINT EDEN WAY Hayward, CA 94545 -3721 |
| Contact | Keith Mullowney |
| Correspondent | Keith Mullowney THERMAGE, INC. 4058 POINT EDEN WAY Hayward, CA 94545 -3721 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-11 |
| Decision Date | 2000-12-08 |