FDA 510(k) Application Details - K241081

Device Classification Name	Tomography, Optical Coherence   More FDA Info for this Device
510(K) Number	K241081
Device Name	Tomography, Optical Coherence
Applicant	Topcon Corporation 75-1 Hasunuma-Cho Itabashi-ku 174-8580 JP Other 510(k) Applications for this Company
Contact	Kitawaki Ryota 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	04/19/2024
Decision Date	07/17/2024
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