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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Laser, Scanning
510(k) Number K261255
Device Name KOWA FM-600
Applicant
Kowa Company, Ltd. Chofu Factory
3-1 Chofugaoka 3-Chome
Chofu
Tokyo,  JP 182-0021
Applicant Contact Kazunori Matsumura
Correspondent
Ken Block Consulting Co., Ltd.
1-9-9 Hosokawatsukiji Bldg., Tsukiji
Cyuo-Ku
Tokyo,  JP 104-0045
Correspondent Contact Nana Nagashita
Regulation Number886.1570
Classification Product Code
MYC  
Date Received04/16/2026
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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