Data / Medical devices / Japan / Kowa Co. Ltd. Chofu

Kowa Co. Ltd. Chofu: FDA-registered device maker in Chofu Tokyo, Japan, 13 510(k) clearances

Name: Kowa Co. Ltd. Chofu FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Kowa Co. Ltd. Chofu is registered with the FDA (registration 3011223751) in Chofu Tokyo, Japan. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 11, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Kowa Co. Ltd. Chofu

FDA registration number: 3011223751
Address: 3-1, Chofugaoka 3-chome, Chofu Tokyo, Japan, 182-0021
Owner or operator: KOWA CO. LTD. (8030217)
Roles: Manufacturer
First device listed: December 24, 2003
Registered through: 2026
Brand names listed: KOWA AP-7000, KOWA APPLANATION TONOMETER HA-1, KOWA APPLANATION TONOMETER HA-2, KOWA DR-1a, KOWA FM-600, KOWA GENESIS-D, KOWA GENESIS-Df, KOWA SL-17 and more

Devices it lists

Device	Product code	Class	Role	Source
Biomicroscope, Slit-Lamp, Ac-Powered	HJO	2	Manufacturer	accessdata.fda.gov
Camera, Ophthalmic, Ac-Powered	HKI	2	Manufacturer	accessdata.fda.gov
Ophthalmoscope, Laser, Scanning	MYC	2	Manufacturer	accessdata.fda.gov
Perimeter, Automatic, Ac-Powered	HPT	1	Manufacturer	accessdata.fda.gov
System, Image Management, Ophthalmic	NFJ	2	Manufacturer	accessdata.fda.gov
Tonometer, Manual	HKY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2026	K261255	KOWA FM-600	MYC	Substantially Equivalent	Kowa Company, Ltd. Chofu Factory	accessdata.fda.gov
November 21, 2022	K222372	Kowa SL-19	HJO	Substantially Equivalent	Kowa Company , Ltd.	accessdata.fda.gov
September 10, 2019	K191945	KOWA nonmyd 8	HKI	Substantially Equivalent	Kowa Company , Ltd.	accessdata.fda.gov
June 4, 2019	K190573	KOWA DR-1a	HKI	Substantially Equivalent	Kowa Company , Ltd.	accessdata.fda.gov
February 12, 2019	K190056	KOWA VK-2s	NFJ	Substantially Equivalent	Kowa Co. Ltd. Chofu	accessdata.fda.gov
March 11, 2014	K133755	KOWA SL-17	HJO	Substantially Equivalent	Kowa Co. , Ltd.	accessdata.fda.gov
February 16, 2012	K112330	KOWA VX-20	HKI	Substantially Equivalent	Kowa Co. , Ltd.	accessdata.fda.gov
January 26, 2011	K101628	KOWA NONMYD WX	HKI	Substantially Equivalent	Kowa Co. , Ltd.	accessdata.fda.gov
August 7, 2009	K091098	KOWAGENESIS-DF	HKI	Substantially Equivalent	Kowa Co. , Ltd.	accessdata.fda.gov
August 7, 2009	K091039	KOWA, FM-600, MODEL LSS50	MYC	Substantially Equivalent	Kowa Co. , Ltd.	accessdata.fda.gov
July 2, 2009	K091683	KOWA VX-10 A	HKI	Substantially Equivalent	Kowa Co. , Ltd.	accessdata.fda.gov
November 3, 2005	K050271	KOWA GENESIS-D HAND-HELD RETINAL CAMERA	HKI	Substantially Equivalent	Kowa Co. , Ltd.	accessdata.fda.gov
June 4, 1996	K960924	KOWA HAND-HELD APPLANATION TONOMETER HA-1	HKY	Substantially Equivalent	Kowa Optimed, Inc.	accessdata.fda.gov

Compare with other makers

Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.