Cleared Traditional

K214028 - MICOR Lens Fragmentation System

K214028 is an FDA 510(k) clearance for MICOR Lens Fragmentation System, manufactured by Carl Zeiss Meditec Cataract Technology, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K214028 · Carl Zeiss Meditec Cataract Technology, Inc. · Ophthalmic device
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Sep 2022
Decision
261d
Days
Class 2
Risk

K214028 is an FDA 510(k) clearance for the MICOR 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 September 9, 2022 after a review of 261 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Carl Zeiss Meditec Cataract Technology, Inc. devices

FDA 510(k) Submission Details - K214028

510(k) Number K214028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2021
Decision Date September 09, 2022
Days to Decision 261 days
Submission Type Traditional
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
151d slower than avg
Panel avg: 110d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

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

All 121
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K214028.
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