The following data is part of a premarket notification filed by Reliant Technologies, Inc. with the FDA for Fraxel Sr Laser System.
| Device ID | K053047 |
| 510k Number | K053047 |
| Device Name: | FRAXEL SR LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | RELIANT TECHNOLOGIES, INC. 260 SHERIDAN AVE. SUITE 300 Palo Alto, CA 94306 |
| Contact | Heather Tanner |
| Correspondent | Heather Tanner RELIANT TECHNOLOGIES, INC. 260 SHERIDAN AVE. SUITE 300 Palo Alto, CA 94306 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-28 |
| Decision Date | 2006-03-20 |
| Summary: | summary |