Cleared Traditional

K081443 - MENICON Z RIGID GAS PERMEABLE CONTACT LENS

K081443 is an FDA 510(k) clearance for MENICON Z RIGID GAS PERMEABLE CONTACT LENS, manufactured by Menicon Co, Ltd.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K081443 · Menicon Co, Ltd. · Ophthalmic device
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Sep 2008
Decision
124d
Days
Class 2
Risk

K081443 is an FDA 510(k) clearance for the MENICON Z RIGID GAS PERMEABLE CONTACT LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Menicon Co, Ltd. (Wilmington, US). The FDA issued a Cleared decision on September 23, 2008 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 Menicon Co, Ltd. devices

FDA 510(k) Submission Details - K081443

510(k) Number K081443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2008
Decision Date September 23, 2008
Days to Decision 124 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
14d slower than avg
Panel avg: 110d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 73
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K081443.
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K071043 · Bausch & Lomb, Inc. · Aug 2007