FDA 510(k) Application Details - K214103

Device Classification Name	Over-The-Counter Powered Light Based Laser For Acne   More FDA Info for this Device
510(K) Number	K214103
Device Name	Over-The-Counter Powered Light Based Laser For Acne
Applicant	Harpar Grace International Unit 4 Imperial Court, Magellan Close, Walworth Business Park, Hampshire Andover SP10 5NT GB Other 510(k) Applications for this Company
Contact	Alana Marie Chalmers 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	12/29/2021
Decision Date	03/22/2022
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