510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982344Substantially Equivalent

Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic Contac Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydrophis

Wesley Jessen Corp., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982344 is the FDA 510(k) clearance record for DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC CONTAC LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPHIS, a class II device, cleared for Wesley Jessen Corp. on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list 11 510(k) clearances for Wesley Jessen Corp., from to . As of , FDA records show no recalls naming K982344.

Clearance record

Decision date
Received
(169 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Wesley Jessen Corp. 333 E. Howard Ave., Des Plaines IL
510(k) summary
Summary
Third party review
No

Clearances, product code LPL

Trailing 12 months
9 clearances under product code LPL in the twelve months to October 2026, May 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code LPL, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20262
April 20261
May 20263
June 20260
July 20260
August 20260
September 20261
October 20260