FDA 510(k) Application Details - K250683

Device Classification Name	Camera, Ophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K250683
Device Name	Camera, Ophthalmic, Ac-Powered
Applicant	Optain Health, Inc. 373 Park Avenue South New York, NY 10016 US Other 510(k) Applications for this Company
Contact	Emilia Gonzalez Other 510(k) Applications for this Contact
Regulation Number	886.1120   More FDA Info for this Regulation Number
Classification Product Code	HKI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2025
Decision Date	04/30/2025
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