The following data is part of a premarket notification filed by Led Technologies, Inc. with the FDA for Dpl Spectralite.
Device ID | K171386 |
510k Number | K171386 |
Device Name: | Dpl SpectraLite |
Classification | Light Based Over The Counter Wrinkle Reduction |
Applicant | LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, CO 80111 |
Contact | Lloyd Nelson |
Correspondent | Jelena Barbaric LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, CO 80111 |
Product Code | OHS |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-05-11 |
Decision Date | 2017-08-07 |
Summary: | summary |