Skip to content

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

by Mi Gwang Contact Lens Co., Ltd.

510(k) K051477

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051477 Date10 Mar 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1257-06 FDA Unclassified (pre-2012) initiated 10 May 2006

    Contact lenses were distributed and sold to inappropriate retail establishments without professional eye care involvement.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent