FDA 510(k) Application Details - K232656

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K232656
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Premier North America Inc. 3301 SW 42nd Street Fort Lauderdale, FL 33312-6828 US Other 510(k) Applications for this Company
Contact	Ellis Tamari 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	08/31/2023
Decision Date	11/14/2023
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