The following data is part of a premarket notification filed by Reliant Technologies, Inc. with the FDA for Fraxel Ii Sr Laser System And Accessories.
| Device ID | K060310 |
| 510k Number | K060310 |
| Device Name: | FRAXEL II SR LASER SYSTEM AND ACCESSORIES |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RELIANT TECHNOLOGIES, INC. 464 ELLIS ST. Mountain View, CA 94043 |
| Contact | Heather Tanner |
| Correspondent | Heather Tanner 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 | 2006-02-07 |
| Decision Date | 2006-03-29 |
| Summary: | summary |