Cleared Traditional

K994021 - CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION

K994021 is an FDA 510(k) clearance for CONTACLAIR MULTI-PURPOSE CONTACT LENS S..., manufactured by Strieter Clinical Research Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K994021 · Strieter Clinical Research Laboratories, Inc. · Ophthalmic device
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Feb 2000
Decision
88d
Days
Class 2
Risk

K994021 is an FDA 510(k) clearance for the CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Strieter Clinical Research Laboratories, Inc. (Collinsville, US). The FDA issued a Cleared decision on February 22, 2000 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Strieter Clinical Research Laboratories, Inc. devices

FDA 510(k) Submission Details - K994021

510(k) Number K994021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date February 22, 2000
Days to Decision 88 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 110d · This submission: 88d
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 K994021.
BPZ02 MULTIPURPOSE SOLUTION
K083757 · Bausch & Lomb, Inc. · Nov 2009
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K022687 · Ciba Vision Corporation · Nov 2002
RENUT MULTIPLUS MULLTI-PURPOSE SOLUTION
K020802 · Bausch & Lomb, Incorporated · May 2002
PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
K991965 · Purilens, Inc. · Oct 1999
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