Cleared Traditional

K884414 - CLENSATRON AUTOMATIC CONTACT LENS CLEANER

K884414 is an FDA 510(k) clearance for CLENSATRON AUTOMATIC CONTACT LENS CLEANER, manufactured by Questech Intl., Inc.. The device is a Class 2 Ophthalmic device with product code LYL cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K884414 · Questech Intl., Inc. · Ophthalmic device
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Dec 1988
Decision
70d
Days
Class 2
Risk

K884414 is an FDA 510(k) clearance for the CLENSATRON AUTOMATIC CONTACT LENS CLEANER. Classified as Accessories, Solution, Ultrasonic Cleaners For Lenses (product code LYL), Class II - Special Controls.

Submitted by Questech Intl., Inc. (Marlboro, US). The FDA issued a Cleared decision on December 29, 1988 after a review of 70 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 Questech Intl., Inc. devices

FDA 510(k) Submission Details - K884414

510(k) Number K884414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date December 29, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 110d · This submission: 70d
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 K884414.
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