The following data is part of a premarket notification filed by Led Technologies, Llc with the FDA for Dpl Nuve.
Device ID | K101382 |
510k Number | K101382 |
Device Name: | DPL NUVE |
Classification | Light Based Over The Counter Wrinkle Reduction |
Applicant | LED TECHNOLOGIES, LLC 4655 KIRKWOOD COURT Boulder, CO 80301 |
Contact | Lewis Ward |
Correspondent | Lewis Ward LED TECHNOLOGIES, LLC 4655 KIRKWOOD COURT Boulder, CO 80301 |
Product Code | OHS |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-05-17 |
Decision Date | 2010-11-09 |
Summary: | summary |