Cleared Traditional

K962006 - MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS

K962006 is an FDA 510(k) clearance for MENICON Z (TISILFOCON A) RIGID GAS PERM..., 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 140-day FDA review.

K962006 · Menicon Co, Ltd. · Ophthalmic device
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Oct 1996
Decision
140d
Days
Class 2
Risk

K962006 is an FDA 510(k) clearance for the MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS. Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Menicon Co, Ltd. (Washington, US). The FDA issued a Cleared decision on October 9, 1996 after a review of 140 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 - K962006

510(k) Number K962006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1996
Decision Date October 09, 1996
Days to Decision 140 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
30d slower than avg
Panel avg: 110d · This submission: 140d
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
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