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KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory vs MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies: FDAPulse comparison

KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory's review days of 148 is 1.3x MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies's 115 (55th percentile). KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory is dated 2026-09-11; MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies 2026-10-15.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe

How does KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory compare to MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies?

FieldKOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu FactoryMICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies
Record510(k) clearance510(k) clearance
510(k) numberK261255K262097
DeviceKOWA FM-600MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)
ApplicantKowa Company, Ltd. Chofu FactoryCarl Zeiss Meditec Cataract Technologies
Specialty / panelOphthalmicOphthalmic
Product codeMYCHQC
Device class22
Clearance typeTraditionalSpecial
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-04-162026-06-22
Decision date2026-09-112026-10-15
Review time (days)148115
Third-party reviewNoNo
Applicant locationTokyo, JPReno, NV, US
amount percentile55th42nd
Predicate Speed & CAPA Advisory Opportunity Score30/10041/100
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Official records: KOWA FM-600 (K261255): 510(k) cleared for Kowa Company, Ltd. Chofu Factory · MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) (K262097): 510(k) cleared for Carl Zeiss Meditec Cataract Technologies

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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