The following data is part of a premarket notification filed by Solta Medical, Inc. with the FDA for Thermage Thermacool Nxt System And Accessories.
| Device ID | K090580 |
| 510k Number | K090580 |
| Device Name: | THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD. Haywood, CA 94043 |
| Contact | Heather Macfalls |
| Correspondent | Heather Macfalls SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD. Haywood, CA 94043 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-03 |
| Decision Date | 2009-06-26 |
| Summary: | summary |