FDA 510(k) Application Details - K250553

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K250553
Device Name	Tomography, Optical Coherence
Applicant	TOMEY Corporation 2-11-33 Noritakeshinmachi, Nishi-ku, Nagoya, Aichi Nagoya 451-0051 JP Other 510(k) Applications for this Company
Contact	Yuko Matsushita Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	OBO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/25/2025
Decision Date	07/18/2025
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