Cleared Traditional

K131875 - MENICON NECT CONTACT LENS CASE

K131875 is an FDA 510(k) clearance for MENICON NECT CONTACT LENS CASE, manufactured by Foresight Regulatory Strategies. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K131875 · Foresight Regulatory Strategies · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
43d
Days
Class 2
Risk

K131875 is an FDA 510(k) clearance for the MENICON NECT CONTACT LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Foresight Regulatory Strategies (Wilmington, US). The FDA issued a Cleared decision on August 6, 2013 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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.

FDA 510(k) Submission Details - K131875

510(k) Number K131875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2013
Decision Date August 06, 2013
Days to Decision 43 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
67d faster than avg
Panel avg: 110d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

Product Code LRX Case, Contact Lens
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LRX Case, Contact Lens

All 67
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K131875.
CONTACT LENS CASE
K140488 · Maca Plastics, Inc. · Sep 2014
POLAROID CONTACTSPOD
K131783 · Viopti, Ltd. · Feb 2014
OWL CONTACT LENS CASES, DOG CONTACT LENS CASES
K130930 · Ningbo Lishunda Electronics Co., Ltd. · Feb 2014
STANDARD CONTACT LENS CASE
K130753 · Watchdog Group, LC · Jun 2013
PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
K122700 · Prosben, Inc. · May 2013
PROGENT LARGE DIAMETER CONTACT LENS CASE FOR RIGID GAS PERMEABLE LENS
K130285 · The Lagado Corp. · Apr 2013
K131875 · MENICON NECT CONTACT LENS CASE
Download PDF FDA Summary Foresight Regulatory …