Cleared Traditional

K052809 - SAUFLON FLAT COLOURED LENS CASE

K052809 is an FDA 510(k) clearance for SAUFLON FLAT COLOURED LENS CASE, 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 29-day FDA review.

K052809 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
29d
Days
Class 2
Risk

K052809 is an FDA 510(k) clearance for the SAUFLON FLAT COLOURED 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 November 2, 2005 after a review of 29 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.

FDA 510(k) Submission Details - K052809

510(k) Number K052809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2005
Decision Date November 02, 2005
Days to Decision 29 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
81d faster than avg
Panel avg: 110d · This submission: 29d
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 67
Devices cleared under the same product code (LRX) and FDA review panel - the closest regulatory comparables to K052809.
POLARIS CONTACT LENS CASE
K093377 · Reliance Design & Manufacturing Corp. · Apr 2010
IMAG, IPOD, EZ-FIND AND ISLIDE
K090362 · Voguestrap · Feb 2009
CONTACT LENS CASE
K071081 · Ningbo Kaida Rubber and Plastic Technology Co., LT · May 2007
SOLO-CARE AQUA ANTIMICROBIAL LENS CASE
K041820 · Ciba Vision Corporation · Sep 2005
I-PROMOTIONS CONTACT LENS CASE
K042578 · I-Promotions, Inc. · Jan 2005
POLYVIAL/POLYPAK, CONTACT LENS CASE AND STORAGE SYSTEM CONTAINER FOR OPHTHALMICS
K040914 · Exero Products, Inc. · May 2004
K052809 · SAUFLON FLAT COLOURED LENS CASE
Download PDF FDA Summary Sauflon Pharmaceutica…