FDA 510(k) clearance · back to tracker

MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)

Carl Zeiss Meditec Cataract Technologies cleared K262097 on 2026-10-15, decision: substantially equivalent

K-number

K262097

Sponsor

Carl Zeiss Meditec Cataract Technologies

Device

MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-10-15

Product code

HQC

Advisory committee

Ophthalmic

Medical specialty

Ophthalmic

Regulation number

886.4670

Official FDA record

Open K262097on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.