510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K201013Substantially Equivalent

Optixon 1-Day

Optixon, Inc., Daegu, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K201013 is the FDA 510(k) clearance record for Optixon 1-Day, a class II device, cleared for Optixon, Inc. on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list one 510(k) clearance for Optixon, Inc. As of , FDA records show no recalls naming K201013.

Clearance record

Decision date
Received
(154 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Optixon, Inc. 105/106 Ho, 164, Obong-Ro, Buk-Gu, Daegu, KR
510(k) summary
Summary PDF
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