Cleared Traditional

K101182 - IOLMASTER 500

K101182 is the FDA 510(k) clearance for IOLMASTER 500 by Carl Zeiss Meditec, AG. It is a Class 2 Ophthalmic device (product code HJO) cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K101182 · Carl Zeiss Meditec, AG · Ophthalmic device
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Nov 2010
Decision
190d
Days
Class 2
Risk

K101182 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 November 3, 2010 after a review of 190 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 K101182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2010
Decision Date November 03, 2010
Days to Decision 190 days
Submission Type Traditional
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
80d slower than avg
Panel avg: 110d · This submission: 190d
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 20
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K101182.
ZEISS CATARACT SUITE MARKERLESS
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IOLMASTER 500
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