MICOR drive

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec Cataract Technology Inc

Identity

Trade Name: MICOR drive FDA UDI
Generic Name: Phacoemulsification system FDA UDI
Device Name: Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector FDA UDI
Model / Reference: FG-50631 FDA UDI
Description: Reusable ophthalmic instrument for the removal of cataracts. Connects to MICOR extractor or MICOR vitrector FDA UDI

Identifiers

Primary DI / UDI-DI: 00860000122375 FDA UDI
510(k) Number: K200584 FDA UDI
FDA Product Code: HQC FDA UDI
GMDN Term: Phacoemulsification system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 886.4670 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Phacoemulsification system

MICOR drive by Carl Zeiss Meditec Cataract Technology Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Phacoemulsification system.

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SOVEREIGN COMPACT — Johnson & Johnson Surgical Vision, Inc. · Class II

Cleared under the same submission

K200584 also covers:

MICOR extractor — Carl Zeiss Meditec Cataract Technology Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Carl Zeiss Meditec Cataract Technology Inc

Sources (1)

FDA UDI eed9a2ce-85ed-4070-abde-e97721134193 35 fields · synced Jun 8, 2026