The following data is part of a premarket notification filed by Solta Medical, Inc. with the FDA for Fraxel Dual 1550/1927 Laser System.
| Device ID | K130193 |
| 510k Number | K130193 |
| Device Name: | FRAXEL DUAL 1550/1927 LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD Hayward, CA 94545 |
| Contact | Raymond Lee |
| Correspondent | Raymond Lee SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD Hayward, CA 94545 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-25 |
| Decision Date | 2013-06-14 |
| Summary: | summary |