The following data is part of a premarket notification filed by Thermage, Inc. with the FDA for Fraxel Re:store Dual Laser System: Model, Mc-sys-sr1500-d-us.
| Device ID | K101490 |
| 510k Number | K101490 |
| Device Name: | FRAXEL RE:STORE DUAL LASER SYSTEM: MODEL, MC-SYS-SR1500-D-US |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | THERMAGE, INC. 25881 INDUSTRIAL BLVD. Hayward, CA 94545 |
| Contact | Kriss Foss |
| Correspondent | Kriss Foss THERMAGE, INC. 25881 INDUSTRIAL BLVD. Hayward, CA 94545 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-01 |
| Decision Date | 2010-09-08 |
| Summary: | summary |