Cleared Traditional

K130805 - MENICON UNIQUE PH MULTI-PURPOSE SOLUTION

K130805 is an FDA 510(k) clearance for MENICON UNIQUE PH MULTI-PURPOSE SOLUTION, manufactured by Menicon Co, Ltd.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K130805 · Menicon Co, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2013
Decision
100d
Days
Class 2
Risk

K130805 is an FDA 510(k) clearance for the MENICON UNIQUE PH MULTI-PURPOSE SOLUTION. 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 July 3, 2013 after a review of 100 days - within the typical 510(k) review window.

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: 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 - K130805

510(k) Number K130805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2013
Decision Date July 03, 2013
Days to Decision 100 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
10d faster than avg
Panel avg: 110d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MRC Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K130805.
Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
K180319 · Bausch and Lomb, Incorporated · Mar 2018
Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
K173089 · Bausch & Lomb, Incorporated · Nov 2017
Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
K173136 · Menicon Co, Ltd. · Nov 2017
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS
K122273 · Menicon Co, Ltd. · Jan 2013
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K082855 · Menicon Co, Ltd. · Mar 2010
BOSTON BL-1000-SIM08 MULTI-ACTION SOLUTION
K024289 · Bausch & Lomb, Incorporated · May 2003