FDA 510(k)

MICOR 700 with Auto I/A

Número K: K243395 · 2025-08-08

RequerenteCarl Zeiss Meditec Cataract Technology, Inc.

Data da decisão2025-08-08

Código do produtoHQC

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

MICOR 700 with Auto I/A 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 2025-08-08 under 510(k) number K243395. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MICOR 700 with Auto I/A?

MICOR 700 with Auto I/A is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K243395.

When did MICOR 700 with Auto I/A receive FDA 510(k) clearance?

MICOR 700 with Auto I/A received FDA 510(k) clearance on 2025-08-08, under 510(k) number K243395.

Who is the listed applicant for MICOR 700 with Auto I/A?

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 with Auto I/A?

The FDA product code for MICOR 700 with Auto I/A is HQC.

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Outros registros que listam Carl Zeiss Meditec Cataract Technology, Inc. como candidato(a)

K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)K214028MICOR Lens Fragmentation System K222236miCOR System Lens Fragmentation System K200207xPORT S Lens Fragmentation System K200584xPORT 304 (miCOR) System Lens Fragmentation System K191024xPORT Lens Fragmentation System

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Fonte oficial

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