Cleared Traditional

ILWAIT TIMER OCULOPRESSOR (K112952) - FDA 510(k) Clearance

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

K112952 · Oryx Medical Pty, Ltd. · Ophthalmic device
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May 2012
Decision
218d
Days
Class 2
Risk

K112952 is an FDA 510(k) clearance for the ILWAIT TIMER OCULOPRESSOR. Classified as Applicator, Ocular Pressure (product code LCC), Class II - Special Controls.

Submitted by Oryx Medical Pty, Ltd. (Maylands, AT). The FDA issued a Cleared decision on May 10, 2012 after a review of 218 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4610 - 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 Oryx Medical Pty, Ltd. devices

Submission Details

510(k) Number K112952 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2011
Decision Date May 10, 2012
Days to Decision 218 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
108d slower than avg
Panel avg: 110d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCC Applicator, Ocular Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4610
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.