MICOR extractor

FDA UDI

Class II (US FDA UDI)

by Carl Zeiss Meditec Cataract Technology Inc

Identity

Trade Name: MICOR extractor FDA UDI
Generic Name: Phacoemulsification system FDA UDI
Device Name: Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631. FDA UDI
Model / Reference: FG-50621 FDA UDI
Description: Disposable ophthalmic instrument for the removal of cataracts. Connects to MICOR drive FG-50631. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860000122368 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

Yes

FDA UDI

Single Use

Yes

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

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Phacoemulsification system

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

Similar devices

Also classified as Phacoemulsification system.

WHITESTAR SIGNATURE — Johnson & Johnson Surgical Vision, Inc. · Class II
WHITESTAR SIGNATURE — Johnson & Johnson Surgical Vision, Inc. · Class II
WHITESTAR TECHNOLOGY — Johnson & Johnson Surgical Vision, Inc. · Class II
UNIVERSAL IV POLE EXTENDER — Johnson & Johnson Surgical Vision, Inc. · Class II
WHITESTAR SIGNATURE — Johnson & Johnson Surgical Vision, Inc. · Class II
WHITESTAR PHACO HANDPIECE — Johnson & Johnson Surgical Vision, Inc. · Class II
WHITESTAR SIGNATURE PRO — Johnson & Johnson Surgical Vision, Inc. · Class II
SOVEREIGN COMPACT — Johnson & Johnson Surgical Vision, Inc. · Class II

Cleared under the same submission

K200584 also covers:

MICOR drive — 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Carl Zeiss Meditec Cataract Technology Inc

Sources (1)

FDA UDI 950eb7cd-38a1-47d1-8341-09b3335aa9ca 35 fields · synced May 30, 2026