FDA 510(k) Application Details - K220543

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K220543
Device Name	Laser, Comb, Hair
Applicant	Auxo Hair, LLC 16300 SW 101 Ave Miami, FL 33157 US Other 510(k) Applications for this Company
Contact	Patricia Schnoor Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	OAP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2022
Decision Date	04/20/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review