The following data is part of a premarket notification filed by On Light Sciences, Inc. with the FDA for Describe Transparent Pfd Patch.
Device ID | K150212 |
510k Number | K150212 |
Device Name: | DeScribe Transparent PFD Patch |
Classification | Transparent Patch For Use In Treatment Of Tattoos |
Applicant | ON Light Sciences, Inc. 7852 Starward Dr. Dublin, CA 94568 |
Contact | David Sell |
Correspondent | Marcy Moore ON Light Sciences, Inc. 131 Kelekent Lane Cary, NC 27518 |
Product Code | PKO |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-01-30 |
Decision Date | 2015-04-20 |
Summary: | summary |