Cleared Traditional

K033656 - SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE

K033656 is an FDA 510(k) clearance for SAUFLON FLAT LENS CASE/SAUFLON 2003 BAR..., manufactured by Sauflon Pharmaceuticals, Ltd.. The device is a Class 2 Ophthalmic device with product code LRX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K033656 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
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Feb 2004
Decision
73d
Days
Class 2
Risk

K033656 is an FDA 510(k) clearance for the SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE. Classified as Case, Contact Lens (product code LRX), Class II - Special Controls.

Submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on February 2, 2004 after a review of 73 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 Sauflon Pharmaceuticals, Ltd. devices

FDA 510(k) Submission Details - K033656

510(k) Number K033656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date February 02, 2004
Days to Decision 73 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
37d faster than avg
Panel avg: 110d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRX Device Classification - Class 2, Special Controls

Product Code LRX Case, Contact Lens
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 - LRX Case, Contact Lens

All 14
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K033656.
Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
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Bausch + Lomb Boston Scleral Lens Case
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SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
CYBERCASES BY BAUSCH & LOMB
K013232 · Bausch & Lomb, Inc. · Nov 2001
ALCON CONTACT LENS CASE
K974281 · Alcon Laboratories · Jan 1998
ALCON CONTACT LENS CASE
K971618 · Alcon Laboratories · Jul 1997