FDA 510(k)

MICOR Lens Fragmentation System

Numéro K : K214028 · 2022-09-09

DemandeurCarl Zeiss Meditec Cataract Technology, Inc.

Date de décision2022-09-09

Code produitHQC

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

MICOR Lens Fragmentation System 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 2022-09-09 under 510(k) number K214028. 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 Lens Fragmentation System?

MICOR Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2022-09-09. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K214028.

When did MICOR Lens Fragmentation System receive FDA 510(k) clearance?

MICOR Lens Fragmentation System received FDA 510(k) clearance on 2022-09-09, under 510(k) number K214028.

Who is the listed applicant for MICOR Lens Fragmentation System?

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 Lens Fragmentation System?

The FDA product code for MICOR Lens Fragmentation System is HQC.

Essais cliniques associés

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Autres dossiers indiquant Carl Zeiss Meditec Cataract Technology, Inc. en tant que demandeur

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Dispositifs connexes (Code : HQC)

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Source officielle

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