Cleared Traditional

K950940 - OPTI PADS

K950940 is an FDA 510(k) clearance for OPTI PADS, manufactured by Karlen Mfg., Inc.. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K950940 · Karlen Mfg., Inc. · Ophthalmic device
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Jun 1995
Decision
119d
Days
Class 2
Risk

K950940 is an FDA 510(k) clearance for the OPTI PADS. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Karlen Mfg., Inc. (St. Charles, US). The FDA issued a Cleared decision on June 26, 1995 after a review of 119 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 Karlen Mfg., Inc. devices

FDA 510(k) Submission Details - K950940

510(k) Number K950940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1995
Decision Date June 26, 1995
Days to Decision 119 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 110d · This submission: 119d
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 11
Devices cleared under the same product code (LYL) and FDA review panel - the closest regulatory comparables to K950940.
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
NEW COMFORT CONTACT LENS CARE ACCESSORY
K962112 · Lens Comfort, Inc. · Nov 1996