Cleared Traditional

K143351 - iCase Contact Lens Case

K143351 is an FDA 510(k) clearance for iCase Contact Lens Case, manufactured by Novabay Pharmaceuticals, Inc.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K143351 · Novabay Pharmaceuticals, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K143351

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Foresight Regulatory Strategies, Inc.
Ellen M Beucler

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LRX Case, Contact Lens

All 38
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K143351.
Contact Lens Case
K162869 · Ningbo Yinzhou Zonghai Artware Co., Ltd. · Dec 2016
Contact Lens Case (multiple brand name)
K160005 · Danyang Chanxin Glasses Cases Factory · Jun 2016
Cat Contact Lens Case, Sunglasses Contact Lens Case, 1st Contact Lens Case, Geeky Eye Contact Lens Case
K142717 · Ni Hau Industrial Co., Ltd. · May 2015
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