The following data is part of a premarket notification filed by Solta Medical, Inc. with the FDA for Clear + Brilliant Laser System.
| Device ID | K120433 |
| 510k Number | K120433 |
| Device Name: | CLEAR + BRILLIANT LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument With Microbeam\fractional Output |
| Applicant | SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD Hayward, CA 94545 |
| Contact | Kristine Foss |
| Correspondent | Kristine Foss SOLTA MEDICAL, INC. 25881 INDUSTRIAL BLVD Hayward, CA 94545 |
| Product Code | ONG |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-13 |
| Decision Date | 2012-04-02 |
| Summary: | summary |