FDA 510(k) Application Details - K183118

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K183118
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	LED Technologies, Inc. 6000 Greenwood Plaza Blvd., Suite 110 Greenwood Village, CO 80111 US Other 510(k) Applications for this Company
Contact	Lloyd Nelson Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OLP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2018
Decision Date	02/07/2019
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