Cleared Traditional

K943784 - MELAFOCON A/RIGID GAS PERM CONTACT LEN FOR DAILY WEAR

K943784 is an FDA 510(k) clearance for MELAFOCON A/RIGID GAS PERM CONTACT LEN ..., 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 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

FDA 510(k) Submission Details - K943784

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
Combination Product No
PCCP Authorized No
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.

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
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K943784.
NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
K955900 · Novavision, Inc. · Mar 1996
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
K954124 · Optical Polymer Research, Inc. · Mar 1996
OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
K952260 · Stellar Contact Lens, Inc. · Jan 1996
BOSTON(R) 7 - 30(ENFLUFOCON A)
K943177 · Polymer Technology Corp. · Aug 1994
BOSTON VII
K942365 · Polymer Technology Corp. · Jun 1994