xPORT 304 (miCOR) System Lens Fragmentation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K200584

by Carl Zeiss Meditec Cataract Technology, Inc.

Identifiers

510(k) Number: K200584 FDA 510(k)
FDA Product Code: HQC FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 886.4670 FDA 510(k)
Regulation Number: 886.4670 FDA 510(k)
Advisory Committee: Ophthalmic FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The xPORT 304 (miCOR) System is a phacofragmentation unit designed for the fragmentation and removal of cataracts. It also supports associated ophthalmic procedures, including irrigation, aspiration, and ancillary functions such as vitreous aspiration and cutting.

This device is classified as a Class II medical device under regulation number 886.4670 and product code HQC. It has received FDA 510(k) clearance for clinical use.

Frequently asked questions

What is the primary clinical use of the xPORT 304 (miCOR) System?

The system is designed for the fragmentation and removal of cataracts. It also supports essential ophthalmic surgical functions, including irrigation, aspiration, and ancillary tasks such as vitreous aspiration and cutting.

What is the regulatory classification of this device?

The xPORT 304 (miCOR) System is classified as a Class II medical device under regulation number 886.4670. It has received FDA 510(k) clearance for clinical use.

Under which product code is this system filed?

The device is filed under product code HQC, which corresponds to phacofragmentation units used in ophthalmic surgery.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: xPORT 304 (miCOR) System Lens Fragmentation System (K200584) — FDA 510 ..., xPORT 304 (miCOR) System Lens Fragmentation System (K200584) - FDA 510 ..., PDF July 31, 2020 - Food and Drug Administration, PDF K200584 - xPORT 304 (miCOR) System Lens Fragmentation System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K200584	Class II	Active

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Manufacturer

Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.

Sources (1)

FDA 510(k) K200584 24 fields · synced Sep 22, 2026