FDA 510(k) Application Details - K242669

Device Classification Name	More FDA Info for this Device
510(K) Number	K242669
Device Name	SnapshotGLO (KB100)
Applicant	Kent Imaging Inc. Suite 300, 1210 8 Street SW Calgary T2R 1L3 CA Other 510(k) Applications for this Company
Contact	Hitalo Arume Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/05/2024
Decision Date	03/26/2025
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