Cleared Traditional

K972443 - MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS

K972443 is an FDA 510(k) clearance for MENICON SF-P AND MENICON Z RIGID GAS PE..., 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 53-day FDA review.

K972443 · 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
Aug 1997
Decision
53d
Days
Class 2
Risk

K972443 is an FDA 510(k) clearance for the MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Menicon U.S.A., Inc. (Clovis, US). The FDA issued a Cleared decision on August 22, 1997 after a review of 53 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K972443

510(k) Number K972443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1997
Decision Date August 22, 1997
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
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 K972443.
ULTRACON/ULTRACON S RIGID GAS PERMEABLE CONTACT LENS FOR DAILY WEAR
K980197 · Specialty Ultravision, Inc. · Aug 1998
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K980741 · Polymer Technology Div. Wilmington Partners, L.P. · May 1998
FLOSI RIGID GAS PERMEABLE CONTACT LENS
K974636 · Futuristic Design Assoc. · Mar 1998
BENZ B17 (KOLFOCON A) RIGID GAS PERMEABLE (HYDROPHOBIC DAILY WEAR CONTACT LENS (CLEAR AND TINTED, LATHE-CUT FROM LENS BL
K963512 · Benz Research and Development Corp. · Jul 1997
BENZ B36 (KOLFOCON B) RIGID GAS PERMEABLE (HYDROPHOBIC) DAILY WEAR CONTACT LENS (TINTED, LATHE-CUT FROM LENS BLANK)
K963744 · Benz Research and Development Corp. · Jul 1997
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
K970698 · Polymer Technology Corp. · May 1997
K972443 · MENICON SF-P AND MENICON Z RIGID GAS PERMEABLE CONTACT LENS
Download PDF FDA Summary Menicon U.S.A., Inc.