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The Tracker / October 2026 / K262097

510(k) cleared

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

Carl Zeiss Meditec Cataract Technologies · Oct 15, 2026 · K262097

FDA cleared the MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621) from Carl Zeiss Meditec Cataract Technologies on Oct 15, 2026 under K262097, a special 510(k). The device falls under product code HQC, Unit, Phacofragmentation, regulated at 21 CFR 886.4670 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jun 22, 2026. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Carl Zeiss Meditec Cataract Technologies has 3 other decisions in the tracker over the last 12 months: K261361 (TORUS Ultrasonic Aspirator System; and accessories (TORUS Single-Use Tubing Sets, TORUS Single-Use Torque Wrenches, TORUS Handpieces, TORUS Tip Packs, TORUS Tip Clearing Stylet)), K260694 (ZEISS CLINIC 360), K253834 (VISUREF 600).

Questions & Answers

What did FDA clear under K262097?

K262097 is the FDA 510(k) for MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621), submitted by Carl Zeiss Meditec Cataract Technologies. FDA's decision date was Oct 15, 2026, under product code HQC (Unit, Phacofragmentation).

Who makes the MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)?

Carl Zeiss Meditec Cataract Technologies, based in Reno, NV, is the applicant of record for K262097.

How long did the K262097 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Oct 15, 2026, 115 days later.

← All decisions in October 2026

Sources