Cleared Traditional

K143351 - iCase Contact Lens Case (FDA 510(k) Clearance)

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

K143351 · Novabay Pharmaceuticals, Inc. · Ophthalmic device
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Apr 2015
Decision
156d
Days
Class 2
Risk

K143351 is an FDA 510(k) clearance for the iCase Contact Lens Case. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Novabay Pharmaceuticals, Inc. (Emeryville, US). The FDA issued a Cleared decision on April 29, 2015 after a review of 156 days - an extended review 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: 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 Novabay Pharmaceuticals, Inc. devices

Submission Details

510(k) Number K143351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2014
Decision Date April 29, 2015
Days to Decision 156 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
46d slower than avg
Panel avg: 110d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 81
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K143351.
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