Cleared Traditional

K032309 - NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY

K032309 is an FDA 510(k) clearance for NOVELENS CONTACT LENS CLEANING ENHANCEM..., manufactured by Novelens, Inc.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K032309 · Novelens, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
132d
Days
Class 2
Risk

K032309 is an FDA 510(k) clearance for the NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Novelens, Inc. (Rockville, US). The FDA issued a Cleared decision on December 4, 2003 after a review of 132 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K032309

510(k) Number K032309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date December 04, 2003
Days to Decision 132 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
22d slower than avg
Panel avg: 110d · This submission: 132d
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 81
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K032309.
I-PROMOTIONS CONTACT LENS CASE
K042578 · I-Promotions, Inc. · Jan 2005
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
K040914 · Exero Products, Inc. · May 2004
SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE
K033656 · Sauflon Pharmaceuticals, Ltd. · Feb 2004
CONTACT LENS STORAGE CASE
K030987 · Pelican Products · Jun 2003
ICASE
K021248 · Ikeeps, Inc. · Sep 2002
CYBERCASES BY BAUSCH & LOMB
K013232 · Bausch & Lomb, Inc. · Nov 2001
K032309 · NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
Download PDF FDA Summary Novelens, Inc.