Cleared Traditional

CONTACT LENS OPHTHALMODYNAMOMETER (K052674) - FDA 510(k) Clearance

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

K052674 · Meditron, GmbH · Ophthalmic device
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May 2006
Decision
239d
Days
Class 2
Risk

K052674 is an FDA 510(k) clearance for the CONTACT LENS OPHTHALMODYNAMOMETER. Classified as Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (pmma) (product code NYK), Class II - Special Controls.

Submitted by Meditron, GmbH (Golden, US). The FDA issued a Cleared decision on May 24, 2006 after a review of 239 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1385 - 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.

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Submission Details

510(k) Number K052674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2005
Decision Date May 24, 2006
Days to Decision 239 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
129d slower than avg
Panel avg: 110d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NYK Ophthalmodynamometer, Diagnostic Contact Lens, Polymethylmethacrylate (pmma)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1385
Definition Pmma Diagnostic Contact Lens Ophthalmodynamometer Is Intended To Be Applied For A Short Period Of Time Directly On The Globe Or Cornea Of The Eye For Diagnosis Of Intraocular Abnormalities. The Device Is Indicated For Examination Of The Ocular Fundus, Vitreous And Retinal Structures, While Manually Applying Force To The Eye With The Contact Lens. The Device Measures And Displays The Amount Of Force That Is Applied To The Eye.
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.