The following data is part of a premarket notification filed by Solta Medical, Inc. with the FDA for Fraxel Re: Store Laser System, Model Sr1500.
| Device ID | K091420 |
| 510k Number | K091420 |
| Device Name: | FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD. Haywood, CA 94043 -2991 |
| Contact | Heather Macfalls |
| Correspondent | Heather Macfalls SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD. Haywood, CA 94043 -2991 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-13 |
| Decision Date | 2009-10-14 |