The following data is part of a premarket notification filed by Solta Medical, Inc. with the FDA for Isolaz 2 Intense Pulsed Light System.
| Device ID | K121515 |
| 510k Number | K121515 |
| Device Name: | ISOLAZ 2 INTENSE PULSED LIGHT SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| 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 | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-22 |
| Decision Date | 2012-06-05 |
| Summary: | summary |