The following data is part of a premarket notification filed by Biorenew Labs, Llc with the FDA for Sonilase Blue, Sonilase Blue-clean, Sonilase Blue-uv Clean Plus.
| Device ID | K152889 |
| 510k Number | K152889 |
| Device Name: | SONILASE BLUE, SONILASE BLUE-CLEAN, SONILASE BLUE-UV CLEAN PLUS |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | BIORENEW LABS, LLC 4154 PIER AVENUE Hermosa Beach, CA 90254 |
| Contact | Jon David |
| Correspondent | Susan Anthoney-dewet AEGIS REGULATORY, INC. 2424 DEMPSTER DRIVE Coralville, IA 52241 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-30 |
| Decision Date | 2015-12-30 |
| Summary: | summary |