FDA 510(k) Application Details - K240616

Device Classification Name	More FDA Info for this Device
510(K) Number	K240616
Device Name	FAQÖ (102)
Applicant	Foreo Inc. 1525 E Pama Lane Las Vegas, NV 89119 US Other 510(k) Applications for this Company
Contact	Evan Feldstein Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PAY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/05/2024
Decision Date	07/15/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review