Cleared Traditional

K112952 - ILWAIT TIMER OCULOPRESSOR

K112952 is an FDA 510(k) clearance for ILWAIT TIMER OCULOPRESSOR, manufactured by Oryx Medical Pty, Ltd.. The device is a Class 2 Ophthalmic device with product code LCC cleared through the Traditional 510(k) pathway after a 218-day FDA review.

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

FDA 510(k) Submission Details - K112952

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.

LCC Device Classification - Class 2, Special Controls

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.