FDA 510(k) Application Details - K190443

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K190443
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	Galactic Beauty, LLC 12 E 87 ST STE 1A New York, NY 10128 US Other 510(k) Applications for this Company
Contact	Ellen Marmur 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	02/25/2019
Decision Date	06/24/2019
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