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
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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.

View all Novelens, Inc. devices

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
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 34
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K032309.
EYE CARE CURE CONTACT LENS CASE
K112832 · Eye Care and Cure · Dec 2011
SOFT GRIP CONTACT LENS CASE, DELUXE CONTACT LENS CASE, ECONO-MATE CONTACT LENS CASE
K111856 · Apothecary Products, Inc. · Jul 2011
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
CYBERCASES BY BAUSCH & LOMB
K013232 · Bausch & Lomb, Inc. · Nov 2001
BONASSE CONTACT LENS CASE
K991206 · Bonasse Ent. Co., Ltd. · Jun 2000
PARAGON LENS CARRIER
K993486 · Paragon Vision Sciences · Dec 1999