Alden Classic (Polymacon) Multifocal (Spherical and Toric), Alden Classic 55 (Methafilcon a) Multifocal (Spherical

• • Terminated Z-0991-2018 FDA Class II ·initiated 3 Nov 2017

  Contact lenses lack sterility assurance.

510(k) Number

K052703 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Alden Hp 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden Hp 54 Multifocal &Hp 54 Toric Multifocal Contact Lenses

  Class II

  FDA 510(k) K091327 Active Cleared 25 Jun 2010

• Al-47 (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Tinted, Lathe-Cut From Lens Blank)

  Class II

  FDA 510(k) K973967 Active Cleared 8 Dec 1997

• Alden Hp (Hioxifilcon B) Sphere & Toric Soft Contact Lenses

  Class II

  FDA 510(k) K042242 Active Cleared 15 Sep 2004

• Novakone Spherical and Toric Lenses

  Class II

  FDA 510(k) K102557 Active Cleared 26 Apr 2011

• Alden Classic Tinted (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens, Tinted (Transparent/Enhancing)

  Class II

  FDA 510(k) K980554 Active Cleared 7 Apr 1998

• Alden Classic Prosthetic (Polymacon) Tinted, Soft Daily Wear Contact Lens (Sighted and Non-Sighted Eyes)

  Class II

  FDA 510(k) K983053 Active Cleared 21 Oct 1998

See all devices from Alden Optical Labs., Inc. →