The following data is part of a premarket notification filed by Led Intellectual Properties, Llc with the FDA for Lightstim For Acne/ Lightstim For Acne Mini.
| Device ID | K131461 |
| 510k Number | K131461 |
| Device Name: | LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI |
| Classification | Over-the-counter Powered Light Based Laser For Acne |
| Applicant | LED INTELLECTUAL PROPERTIES, LLC 16552 VON KARMAN AVE. Irvine, CA 92606 |
| Contact | Steve Marchese |
| Correspondent | Steve Marchese LED INTELLECTUAL PROPERTIES, LLC 16552 VON KARMAN AVE. Irvine, CA 92606 |
| Product Code | OLP |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-20 |
| Decision Date | 2014-01-06 |
| Summary: | summary |