Cleared Traditional

K011456 - DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES

K011456 is an FDA 510(k) clearance for DELTA PLUS MULTIACTION SOLUTION FOR RIG..., manufactured by Sauflon Pharmaceuticals, Ltd.. The device is a Class 2 Ophthalmic device with product code MRC cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K011456 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
67d
Days
Class 2
Risk

K011456 is an FDA 510(k) clearance for the DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES. Classified as Products, Contact Lens Care, Rigid Gas Permeable (product code MRC), Class II - Special Controls.

Submitted by Sauflon Pharmaceuticals, Ltd. (Chicago, US). The FDA issued a Cleared decision on July 17, 2001 after a review of 67 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.

FDA 510(k) Submission Details - K011456

510(k) Number K011456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2001
Decision Date July 17, 2001
Days to Decision 67 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
43d faster than avg
Panel avg: 110d · This submission: 67d
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 32
Devices cleared under the same product code (MRC) and FDA review panel - the closest regulatory comparables to K011456.
MENICON PROGENT REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES
K020930 · Menicon Co, Ltd. · May 2002
AQUIFY LENS COMFORT DROPS
K013204 · Ciba Vision Corporation · Apr 2002
MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND
K014162 · Lobob Laboratories, Inc. · Jan 2002
MENICON PROGENT REMOVER
K002140 · Menicon Co, Ltd. · Oct 2000
LIPIDURE REWETTING DROPS
K000975 · Nof Corp. · Sep 2000
OPTIMUM CLEANING, DISINFECTING AND STORAGE SOLUTION
K001964 · Lobob Laboratories, Inc. · Jul 2000
K011456 · DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES
Download PDF FDA Summary Sauflon Pharmaceutica…