Alcon Multi-Purpose Disinfecting Solution

• • Ongoing Z-1590-2022 FDA Class II ·initiated 25 May 2022

  Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

510(k) Number

K050729 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K062930 Active Cleared 8 Nov 2006

• Clearcut S Safety Knife Open recall

  Class I

  FDA 510(k) K110166 Active Cleared 20 May 2011

• CENTURION Vision System (Active SentryTM)

  Class II

  FDA 510(k) K161794 Active Cleared 14 Apr 2017

• Monarch II IOL Delivery System

  Class I

  FDA 510(k) K001157 Active Cleared 27 Jun 2000

• Wavelight FS200 Laser System Model: FS200

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  FDA 510(k) K101006 Active Cleared 21 Oct 2010

• Alcon Multi-Pirpose Disinfecting Solution

  Class II

  FDA 510(k) K102860 Active Cleared 10 May 2011

See all devices from Alcon Research, Ltd. →