FDA 510(k) Application Details - K180875

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K180875
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Medtek Skincare, LLC 3 Depot Street Hudson Falls, NY 12839 US Other 510(k) Applications for this Company
Contact	Gary Richardson Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2018
Decision Date	09/14/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review