Cleared Traditional

K173136 - Menicon Progent Protein Remover for Rig...

K173136 is the FDA 510(k) clearance for Menicon Progent Protein Remover for Rig... by Menicon Co, Ltd.. It is a Class 2 Ophthalmic device (product code MRC) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K173136 · Menicon Co, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
48d
Days
Class 2
Risk

K173136 is an FDA 510(k) clearance for the Menicon Progent Protein 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. (Nagoya, JP). The FDA issued a Cleared decision on November 16, 2017 after a review of 48 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 K173136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date November 16, 2017
Days to Decision 48 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
62d faster than avg
Panel avg: 110d · This submission: 48d
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

All 8
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K173136.
Nutrifill
K181566 · Contamac, Ltd. · Oct 2018
Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner
K181627 · Bausch & Lomb, Incorporated · Aug 2018
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
K180319 · Bausch and Lomb, Incorporated · Mar 2018
RGP MULTI-PURPOSE SOLUTION ID 100136
K000148 · Alcon Laboratories · Apr 2000