The following data is part of a premarket notification filed by Reliant Technologies, Inc. with the FDA for Fraxel Re:pair (fraxel Iii Sr) Laser System And Accessories.
| Device ID | K080915 |
| 510k Number | K080915 |
| Device Name: | FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RELIANT TECHNOLOGIES, INC. 464 ELLIS ST. Mountain View, CA 94043 |
| Contact | Heather Macfalls |
| Correspondent | Heather Macfalls RELIANT TECHNOLOGIES, INC. 464 ELLIS ST. Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-02 |
| Decision Date | 2008-07-01 |
| Summary: | summary |