Cleared Traditional

K011456 - DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011456 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
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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.

View all Sauflon Pharmaceuticals, Ltd. devices

Submission Details

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
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.

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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