Cleared Traditional

K974485 - SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION

K974485 is an FDA 510(k) clearance for SAUFLON ALL-IN-ONE LIGHT CONTACT LENS S..., manufactured by Szabocsik and Assoc.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974485 · Szabocsik and Assoc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
90d
Days
Class 2
Risk

K974485 is an FDA 510(k) clearance for the SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Szabocsik and Assoc. (Chicago, US). The FDA issued a Cleared decision on February 24, 1998 after a review of 90 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 Szabocsik and Assoc. devices

FDA 510(k) Submission Details - K974485

510(k) Number K974485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1997
Decision Date February 24, 1998
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPN Device Classification - Class 2, Special Controls

Product Code LPN Accessories, Soft Lens Products
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 - LPN Accessories, Soft Lens Products

All 80
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K974485.
RENU MULTIPLUS MULTI-PURPOSE SOLUTION
K974723 · Bausch & Lomb, Inc. · Mar 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K974624 · Alcon Laboratories · Mar 1998
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K974625 · Alcon Laboratories · Mar 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · Bausch & Lomb, Inc. · Jan 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · Alcon Laboratories · Dec 1997
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · Polymer Technology Corp. · Nov 1997