Cleared Traditional

K962112 - NEW COMFORT CONTACT LENS CARE ACCESSORY

K962112 is an FDA 510(k) clearance for NEW COMFORT CONTACT LENS CARE ACCESSORY, manufactured by Lens Comfort, Inc.. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K962112 · Lens Comfort, Inc. · Ophthalmic device
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Nov 1996
Decision
182d
Days
Class 2
Risk

K962112 is an FDA 510(k) clearance for the NEW COMFORT CONTACT LENS CARE ACCESSORY. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Lens Comfort, Inc. (Elizabeth, US). The FDA issued a Cleared decision on November 29, 1996 after a review of 182 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 Lens Comfort, Inc. devices

FDA 510(k) Submission Details - K962112

510(k) Number K962112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1996
Decision Date November 29, 1996
Days to Decision 182 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
72d slower than avg
Panel avg: 110d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LYL Device Classification - Class 2, Special Controls

Product Code LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
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 - LYL Accessories, Solution, Ultrasonic Cleaners For Lenses

All 10
Devices cleared under the same product code (LYL) and FDA review panel - the closest regulatory comparables to K962112.
LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
K982115 · Rim-Wide Companies, Inc. · Jan 1999
SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
K974724 · Lens Comfort, Inc. · Mar 1998
ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
K964222 · Paladin Medical, Inc. · Dec 1996