The following data is part of a premarket notification filed by Biorenew Labs, Llc with the FDA for Sonilase Light Therapy Device.
| Device ID | K132613 |
| 510k Number | K132613 |
| Device Name: | SONILASE LIGHT THERAPY DEVICE |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | BIORENEW LABS, LLC 2424 DEMPSTER DRIVE Coralville, IA 52241 |
| Contact | Susan Anthoney |
| Correspondent | Susan Anthoney BIORENEW LABS, LLC 2424 DEMPSTER DRIVE Coralville, IA 52241 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-21 |
| Decision Date | 2014-02-05 |
| Summary: | summary |