FDA 510(k)

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)

Numéro K : K242801 · 2025-06-11

DemandeurCarl Zeiss Meditec Cataract Technology, Inc.

Date de décision2025-06-11

Code produitHQC

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. It received FDA 510(k) clearance on 2025-06-11 under 510(k) number K242801. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)?

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) is a medical device that received FDA 510(k) clearance on 2025-06-11. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K242801.

When did MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) receive FDA 510(k) clearance?

MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) received FDA 510(k) clearance on 2025-06-11, under 510(k) number K242801.

Who is the listed applicant for MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)?

The FDA 510(k) record lists Carl Zeiss Meditec Cataract Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)?

The FDA product code for MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185) is HQC.

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Source officielle

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