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)
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.

View all Menicon U.S.A., Inc. devices

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 47
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K972443.
RIGID GAS PERMEABLE CONTACT LENS
K013762 · Bausch & Lomb, Incorporated · Apr 2002
RIGID GAS PERMEABLE CONTACT LENS SOLUTION
K011945 · Polymer Technology Corp. · Sep 2001
MENICON SF-P
K000233 · Menicon Co, Ltd. · May 2000
BOSTON ES MULTIVISION (ENFLUFOCON A) CONTACT LENS
K970698 · Polymer Technology Corp. · May 1997
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
K962006 · Menicon Co, Ltd. · Oct 1996
MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR
K943784 · Menicon Co, Ltd. · Oct 1994