Cleared Special

K222236 - miCOR System Lens Fragmentation System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K222236 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic device
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Aug 2022
Decision
29d
Days
Class 2
Risk

K222236 is an FDA 510(k) clearance for the miCOR System Lens Fragmentation System. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Carl Zeiss Meditec Cataract Technology, Inc. (Reno, US). The FDA issued a Cleared decision on August 24, 2022 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Carl Zeiss Meditec Cataract Technology, Inc. devices

Submission Details

510(k) Number K222236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2022
Decision Date August 24, 2022
Days to Decision 29 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

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