The following data is part of a premarket notification filed by Led Technologies, Llc with the FDA for Nuve For Wrinkles, Dpl Nuve For Wrinkles.
Device ID | K141181 |
510k Number | K141181 |
Device Name: | NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES |
Classification | Light Based Over The Counter Wrinkle Reduction |
Applicant | LED TECHNOLOGIES, LLC 2424 DEMPSTER DR. Coralville, IA 52241 |
Contact | Susan Anthoney-dewet |
Correspondent | Susan Anthoney-dewet LED TECHNOLOGIES, LLC 2424 DEMPSTER DR. 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 | 2014-05-07 |
Decision Date | 2015-03-31 |
Summary: | summary |