FDA 510(k)

xPORT S Lens Fragmentation System

Numéro K : K200207 · 2020-10-15

DemandeurCarl Zeiss Meditec Cataract Technology, Inc.

Date de décision2020-10-15

Code produitHQC

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

xPORT S 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 2020-10-15 under 510(k) number K200207. 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 xPORT S Lens Fragmentation System?

xPORT S Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2020-10-15. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K200207.

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

xPORT S Lens Fragmentation System received FDA 510(k) clearance on 2020-10-15, under 510(k) number K200207.

Who is the listed applicant for xPORT S 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 xPORT S Lens Fragmentation System?

The FDA product code for xPORT S Lens Fragmentation System is HQC.

Essais cliniques associés

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Dispositifs connexes (Code : HQC)

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Source officielle

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