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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261255

510(k) cleared

KOWA FM-600

Kowa Company, Ltd. Chofu Factory · Sep 11, 2026 · K261255

FDA cleared the KOWA FM-600 from Kowa Company, Ltd. Chofu Factory on Sep 11, 2026 under K261255, a traditional 510(k). The device falls under product code MYC, Ophthalmoscope, Laser, Scanning, regulated at 21 CFR 886.1570 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Apr 16, 2026. The decision came 148 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Kowa Company, Ltd. Chofu Factory in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261255?

K261255 is the FDA 510(k) for KOWA FM-600, submitted by Kowa Company, Ltd. Chofu Factory. FDA's decision date was Sep 11, 2026, under product code MYC (Ophthalmoscope, Laser, Scanning).

Who makes the KOWA FM-600?

Kowa Company, Ltd. Chofu Factory, based in Tokyo, is the applicant of record for K261255.

How long did the K261255 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Sep 11, 2026, 148 days later.

← All decisions in September 2026