510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051477Substantially Equivalent

Migwang Comfort 38 (Polymacon) Spherical and Toric Soft Contact Lens for Daily Wear (Clear, Tinted and Cosmetic)

MI Gwang Contact Lens Co., Ltd., Grand Junction CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051477 is the FDA 510(k) clearance record for MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC), a class II device, cleared for Mi Gwang Contact Lens Co., Ltd. on under FDA product code LPL (Lenses, Soft Contact, Daily Wear). FDA records list one 510(k) clearance for Mi Gwang Contact Lens Co., Ltd. As of , FDA records show one recall naming K051477.

Clearance record

Decision date
Received
(280 days to decision)
Product code
LPL Lenses, Soft Contact, Daily Wear
Regulation
21 CFR 886.5925
Device class
Class II
Review panel
Ophthalmic
Applicant
Mi Gwang Contact Lens Co., Ltd. 2214 Sanford Dr., Grand Junction CO
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