510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K033656Substantially Equivalent

Sauflon Flat Lens Case/sauflon 2003 Barrel Lens Case

Sauflon Pharmaceuticals, Ltd., Twickenham, Middlesex, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K033656 is the FDA 510(k) clearance record for SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE, a class II device, cleared for Sauflon Pharmaceuticals, Ltd. on under FDA product code LRX (Case, Contact Lens). FDA records list 12 510(k) clearances for Sauflon Pharmaceuticals, Ltd., from to . As of , FDA records show no recalls naming K033656.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LRX Case, Contact Lens
Regulation
21 CFR 886.5928
Device class
Class II
Review panel
Ophthalmic
Applicant
Sauflon Pharmaceuticals, Ltd. 49-53 York St., Twickenham, Middlesex, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRX

Trailing 12 months
1 clearance under product code LRX in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LRX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260