FDA 510(k) Application Details - K170111

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K170111
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Pulsaderm LLC 12801 COMMONWEALTH DR. UNITS 2-6 Fort Myers, FL 33913 US Other 510(k) Applications for this Company
Contact	Gloria Avendano 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	01/12/2017
Decision Date	05/08/2017
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