DURASOFT FRESHLOOK UV COLORS - Durasoft 3 Freshlook Uv Lite Tint

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

510(k) Number

K954603 ↗

FDA Product Code

LPL

Models / Variants

Durasoft Freshlook Uv Colors

Durasoft 3 Freshlook Uv Lite Tint

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Gentle Touch UV (Netrafilcon A) Soft Contact Lenses

  Class II

  FDA 510(k) K991000 Active Cleared 28 Jun 1999

• Durasoft 2 (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 2 (Phemfilcon a) Sherical ( Hydrophilic)C

  Class II

  FDA 510(k) K000439 Active Cleared 20 Mar 2000

• Prosoft (Phemfilcon) Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K994335 Active Cleared 20 Mar 2000

• Durasoft 3 UV (Phemfilcon a) Optifit Toric (Hydrophilic) Contact Lenses, Durasoft 3 UV (Phemfilcon a) Spherical (Hydropi

  Class II

  FDA 510(k) K993935 Active Cleared 21 Dec 1999

• Precision UV (Vasurfilcon a)

  Class II

  FDA 510(k) K982988 Active Cleared 6 Jan 1999

• Rurasoft 2 Freshlook Colors; Durasoft 2 Freshlook Litetint

  Class II

  FDA 510(k) K962957 Active Cleared 1 Oct 1996

See all devices from Wesley Jessen Corp. →