Cleared Traditional

K101182 - IOLMASTER 500

K101182 is an FDA 510(k) clearance for IOLMASTER 500, manufactured by Carl Zeiss Meditec, AG. The device is a Class 2 Ophthalmic device with 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

FDA 510(k) Submission Details - K101182

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.

HJO Device Classification - Class 2, Special Controls

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 57
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K101182.
IOLMASTER 500
K122418 · Carl Zeiss Meditec, AG · Apr 2013
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K110129 · Rightmedical Products, LLC · Aug 2011
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K110489 · Topcon Medical Systems, Inc. · May 2011
PSL CLASSIC SLIT LAMP
K100500 · Keeler Instruments, Inc. · Mar 2010
KOWA SL-15
K063640 · Kowa Co. , Ltd. · Dec 2006
DOCUMENTING LASER SLIT LAMP, DP 2010
K012873 · Bausch & Lomb, Inc. · Nov 2001