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

• • Terminated Z-0983-2018 FDA Class II ·initiated 3 Nov 2017

  Contact lenses lack sterility assurance.

510(k) Number

K973967 ↗

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

• 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

• IO2 Spher(Mangofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, IO2 Toric (Mangofilcon a) Soft (Hydrophilic)

  Class II

  FDA 510(k) K133079 Active Cleared 17 Dec 2013

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