Dailies (Nelfilcon a) One-Day Soft Contact Lens

• • Terminated Z-0827-03 FDA Unclassified (pre-2012) ·initiated 6 May 2003

  Lenses may be labeled with the incorrect axis.

510(k) Number

K963487 ↗

FDA Product Code

LPL

Device Class

Class II

Regulation

21 CFR Part 886.5925

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Focus Dailies Visitint (Nelfilcon a) One-Day Contact Lens

  Class II

  FDA 510(k) K984273 Active Cleared 25 Jan 1999

• Aquify Lens Comfort Drops

  Class II

  FDA 510(k) K042176 Active Cleared 3 Nov 2004

• Glitter Eyes (Tefilcon) Soft (Hydrophilic) Contact Lens for Daily Wear

  Class II

  FDA 510(k) K003071 Active Cleared 13 Dec 2000

• Aosept Plus Cleaning and Disinfecting Solution

  Class II

  FDA 510(k) K003345 Active Cleared 26 Mar 2001

• Aosept Clear Care Cleaning and Disinfecting Solution

  Class II

  FDA 510(k) K023455 Active Cleared 28 Feb 2003

• Modification to Karats Multi-Purpose Solution

  Class II

  FDA 510(k) K031957 Active Cleared 14 Aug 2003

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