Cleared Traditional

K122418 - IOLMASTER 500

K122418 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 247-day FDA review.

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

FDA 510(k) Submission Details - K122418

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
Combination Product No
PCCP Authorized No
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.

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 K122418.
KOWA SL-17
K133755 · Kowa Co. , Ltd. · Mar 2014
SLIT LAMPS WITH SL CAM 5.0 DIGITAL IMAGING SOLUTION
K133476 · Carl Zeiss Meditec, AG · Feb 2014
KEELER SLIT LAMP H-SERIES
K131589 · Keeler, Ltd. · Jun 2013
RIGHTON ZOOM SLIT LAMP MICROSCOPE WITH PHOTO OPTION
K110129 · Rightmedical Products, LLC · Aug 2011
SLIT LAMP SL-2G
K110489 · Topcon Medical Systems, Inc. · May 2011
IOLMASTER 500
K101182 · Carl Zeiss Meditec, AG · Nov 2010