Cleared Traditional

K013649 - SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS

K013649 is an FDA 510(k) clearance for SAUFLON 55 UV SOFT (HYDROPHILIC) CONTAC..., manufactured by Sauflon Pharmaceuticals, Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K013649 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
51d
Days
Class 2
Risk

K013649 is an FDA 510(k) clearance for the SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on December 26, 2001 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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 Sauflon Pharmaceuticals, Ltd. devices

FDA 510(k) Submission Details - K013649

510(k) Number K013649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2001
Decision Date December 26, 2001
Days to Decision 51 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
59d faster than avg
Panel avg: 110d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 - LPL Lenses, Soft Contact, Daily Wear

All 170
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K013649.
CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K023732 · Ciba Vision Corporation · Dec 2002
FREQUENCY 55 UV (METHAFILCON A) SOFT (HYDROPHLIC) CONTACT LENS FOR DAILY WEAR
K020392 · CooperVision, Inc. · Apr 2002
FOCUS EXCELENS (LOTRAFILCON B) SPHERICAL, TORIC AND MULTIFOCAL DESIGN
K020139 · Ciba Vision Corporation · Apr 2002
GLITTER EYES (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K003071 · Ciba Vision Corporation · Dec 2000
METHAFILCON A
K002625 · CooperVision, Inc. · Sep 2000
POLYMACON
K001089 · CooperVision, Inc. · May 2000