Cleared Traditional

K943784 - MELAFOCON A/RIGID GAS PERM CONTACT LEN ...

K943784 is the FDA 510(k) clearance for MELAFOCON A/RIGID GAS PERM CONTACT LEN ... by Menicon Co, Ltd.. It is a Class 2 Ophthalmic device (product code HQD) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K943784 · Menicon Co, Ltd. · Ophthalmic device
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Oct 1994
Decision
86d
Days
Class 2
Risk

K943784 is an FDA 510(k) clearance for the MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR. 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 20, 1994 after a review of 86 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 Co, Ltd. devices

Submission Details

510(k) Number K943784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1994
Decision Date October 20, 1994
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K943784.
BOSTON RGP LENSES WET SHIPPED IN BOSTOM SIMPLUS MULTI-ACTION SOLUTION AND STORED FOR UP TO 30 DAYS
K073184 · Bausch & Lomb, Inc. · Feb 2008
BOSTON X02 (HEXAFOCON B) RIGID GAS PERMEABLE CONTACT LENS
K071266 · Bausch & Lomb, Inc. · Aug 2007
BOSTON XO (HEXAFOCON A), BOSTON EO (ENFLUFOCON B) AND BOSTON ES (ENFLUFOCON A) RIGID GAS PERMEABLE CONTACT LENSES
K071043 · Bausch & Lomb, Inc. · Aug 2007