Cleared Special

K262097 - MICOR 700 System (N/A)

Also marketed or referenced as:
MICOR 700 Extractor (FG-50621)

K262097 is an FDA 510(k) clearance for MICOR 700 System (N/A), manufactured by Carl Zeiss Meditec Cataract Technologies. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Special 510(k) pathway after a 115-day FDA review.

K262097 · Carl Zeiss Meditec Cataract Technologies · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
115d
Days
Class 2
Risk

K262097 is an FDA 510(k) clearance for the MICOR 700 System (N/A). Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Carl Zeiss Meditec Cataract Technologies (Reno, US). The FDA issued a Cleared decision on October 15, 2026 after a review of 115 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K262097

510(k) Number K262097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2026
Decision Date October 15, 2026
Days to Decision 115 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 110d · This submission: 115d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

GSM Services, Inc.
Gary Mocnik

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQC Unit, Phacofragmentation

All 315
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Download PDF FDA Summary Carl Zeiss Meditec Ca…