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FDA 510(k)

xPORT Lens Fragmentation System

K-Number: K191024 · 2019-08-13

ApplicantCarl Zeiss Meditec Cataract Technology, Inc.
Decision Date2019-08-13
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

xPORT 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 2019-08-13 under 510(k) number K191024. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the xPORT Lens Fragmentation System?

xPORT Lens Fragmentation System is a medical device that received FDA 510(k) clearance on 2019-08-13. The listed applicant is Carl Zeiss Meditec Cataract Technology, Inc.. The 510(k) number is K191024.

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

xPORT Lens Fragmentation System received FDA 510(k) clearance on 2019-08-13, under 510(k) number K191024.

Who is the listed applicant for xPORT 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 Lens Fragmentation System?

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

Other records listing Carl Zeiss Meditec Cataract Technology, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243395MICOR 700 with Auto I/AK242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)K214028MICOR Lens Fragmentation SystemK222236miCOR System Lens Fragmentation SystemK200207xPORT S Lens Fragmentation SystemK200584xPORT 304 (miCOR) System Lens Fragmentation System

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Related Devices (Code: HQC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423); 23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B); 25 ga. Posterior Elite™ Pack (SE5425); 25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B); 27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B); 23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+); 25 ga. Bi-Blade™+Bausch and LombK252052Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 with Auto I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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