Cleared Traditional

K010559 - SAUFLON MULTI LENS CARE SYSTEM

K010559 is an FDA 510(k) clearance for SAUFLON MULTI LENS CARE SYSTEM, manufactured by Sauflon Pharmaceuticals, Ltd.. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K010559 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
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Dec 2001
Decision
297d
Days
Class 2
Risk

K010559 is an FDA 510(k) clearance for the SAUFLON MULTI LENS CARE SYSTEM. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on December 20, 2001 after a review of 297 days - an extended review 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: 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 Sauflon Pharmaceuticals, Ltd. devices

FDA 510(k) Submission Details - K010559

510(k) Number K010559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date December 20, 2001
Days to Decision 297 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
187d slower than avg
Panel avg: 110d · This submission: 297d
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 72
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K010559.
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K014202 · Allergan, Inc. · Feb 2002
COMPLETE BRAND MULTI-PURPOSE SOLUTION
K013479 · Allergan, Inc. · Feb 2002
SOLO-CARE PLUS MULTIPURPOSE SOLUTION
K012731 · Ciba Vision Corporation · Dec 2001
AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION
K013512 · Ciba Vision Corporation · Dec 2001
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION
K011796 · Bausch & Lomb, Inc. · Nov 2001
AOSEPT PLUS CLEANING AND DISINFECTING SOLUTION
K003345 · Ciba Vision Corporation · Mar 2001