FDA 510(k) Application Details - K230825

Device Classification Name	More FDA Info for this Device
510(K) Number	K230825
Device Name	Smileyscope System (Therapy Mode)
Applicant	Smileyscope Holding Inc. 701 Tillery Street #12 Austin, TX 78702 US Other 510(k) Applications for this Company
Contact	Paul Leong Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2023
Decision Date	09/25/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review