Cleared Traditional

K122418 - IOLMASTER 500 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K122418 · Carl Zeiss Meditec, AG · Ophthalmic device
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Apr 2013
Decision
247d
Days
Class 2
Risk

K122418 is an FDA 510(k) clearance for the IOLMASTER 500. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on April 12, 2013 after a review of 247 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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, AG devices

Submission Details

510(k) Number K122418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2012
Decision Date April 12, 2013
Days to Decision 247 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 110d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 107
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