The following data is part of a premarket notification filed by Led Intellectual Properties, Llc with the FDA for Lightstim Professional 2-panel Light.
Device ID | K150098 |
510k Number | K150098 |
Device Name: | LightStim Professional 2-Panel Light |
Classification | Light Based Over The Counter Wrinkle Reduction |
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 | OHS |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-20 |
Decision Date | 2015-04-09 |
Summary: | summary |