Cleared Traditional

K974724 - SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT

K974724 is an FDA 510(k) clearance for SOFTMATE AUTOMATIC LENS CLEANING UNIT, 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 74-day FDA review.

K974724 · Lens Comfort, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
74d
Days
Class 2
Risk

K974724 is an FDA 510(k) clearance for the SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LE.... 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 March 2, 1998 after a review of 74 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 Lens Comfort, Inc. devices

FDA 510(k) Submission Details - K974724

510(k) Number K974724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1997
Decision Date March 02, 1998
Days to Decision 74 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
36d faster than avg
Panel avg: 110d · This submission: 74d
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 K974724.
CONTACLAIR MULTI-PURPOSE CONTACT LENS SOLUTION
K994021 · Strieter Clinical Research Laboratories, Inc. · Feb 2000
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
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