FDA 510(k) Application Details - K241931

Device Classification Name	Ophthalmoscope,Laser,Scanning   More FDA Info for this Device
510(K) Number	K241931
Device Name	Ophthalmoscope,Laser,Scanning
Applicant	OcuSciences, Inc. 2890 Carpenter Rd Suite 1800 Ann Arbor, MI 48108 US Other 510(k) Applications for this Company
Contact	Kurt Riegger Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	MYC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2024
Decision Date	04/22/2025
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