FDA 510(k) Application Details - K210545

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K210545
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Marci Beauty Inc 4290 Cameron St Unit 7 Las Vegas, NV 89103 US Other 510(k) Applications for this Company
Contact	Shaul Rappaport 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	02/25/2021
Decision Date	05/20/2022
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