FDA 510(k) Application Details - K242786

Device Classification Name	More FDA Info for this Device
510(K) Number	K242786
Device Name	TearCare MGX System
Applicant	Sight Sciences, Inc. 4040 Campbell Avenue Suite 100 Menlo Park, CA 94025 US Other 510(k) Applications for this Company
Contact	Rachel Franco Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	ORZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/2024
Decision Date	04/15/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review