Cleared Traditional

K020930 - MENICON PROGENT REMOVER FOR RIGID GAS P...

K020930 is the FDA 510(k) clearance for MENICON PROGENT REMOVER FOR RIGID GAS P... by Menicon Co, Ltd.. It is a Class 2 Ophthalmic device (product code MRC) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K020930 · Menicon Co, Ltd. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
41d
Days
Class 2
Risk

K020930 is an FDA 510(k) clearance for the MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Menicon Co, Ltd. (Wilmington, US). The FDA issued a Cleared decision on May 2, 2002 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5918 - 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 K020930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2002
Decision Date May 02, 2002
Days to Decision 41 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 110d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MRC Products, Contact Lens Care, Rigid Gas Permeable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5918
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 - MRC Products, Contact Lens Care, Rigid Gas Permeable

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