CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear,

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K150590 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023989 Active Cleared 26 Feb 2003

• OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K180616 Active Cleared 25 Apr 2018

• Contaflex 38 (Polymacon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut)

  Class II

  FDA 510(k) K023987 Active Cleared 26 Feb 2003

• Hyper GP (tisilfocon A) Daily Wear Contact Lens

  Class II

  FDA 510(k) K182304 Active Cleared 23 Nov 2018

• OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

  Class II

  FDA 510(k) K160859 Active Cleared 13 Jul 2016

• Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses

  Class II

  FDA 510(k) K212631 Active Cleared 17 Mar 2022

See all devices from Contamac, Ltd. →