Cleared Traditional

K000133 - MENICON Z

K000133 is an FDA 510(k) clearance for MENICON Z, manufactured by Menicon U.S.A., Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K000133 · Menicon U.S.A., Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
122d
Days
Class 2
Risk

K000133 is an FDA 510(k) clearance for the MENICON Z. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Menicon U.S.A., Inc. (Wilmington, US). The FDA issued a Cleared decision on May 19, 2000 after a review of 122 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.

FDA 510(k) Submission Details - K000133

510(k) Number K000133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date May 19, 2000
Days to Decision 122 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
12d slower than avg
Panel avg: 110d · This submission: 122d
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 115
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K000133.
RIGID GAS PERMEABLE CONTACT LENS
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RIGID GAS PERMEABLE CONTACT LENS
K000795 · Polymer Technology · May 2000
SPORTSIGHT GP
K993586 · Paragon Vision Sciences · May 2000
MENICON SF-P
K000233 · Menicon Co, Ltd. · May 2000
HYDRO2, HS-75
K000485 · Innovision, Inc. · May 2000
EPICON (CARBOSILFOCON A) RIGID GAS PERMEABLE CONTACT LENS DAILY WEAR
K992787 · Specialty Ultravision, Inc. · Feb 2000
K000133 · MENICON Z
Download PDF FDA Summary Menicon U.S.A., Inc.