Sauflon Aerotab Disinfecting System for Soft (Hydrophilic) Contact Lenses

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

Full name

Sauflon Aerotab Disinfecting System for the Disinfection of Soft (Hydrophilic) Contact Lenses

510(k) Number

K991125 ↗

FDA Product Code

LPN

Device Class

Class II

Regulation

21 CFR Part 886.5928

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Sauflon Multipurpose Solution No Rub

  Class II

  FDA 510(k) K030278 Active Cleared 30 Jul 2003

• Sauflon Multi Lens Care System

  Class II

  FDA 510(k) K010559 Active Cleared 20 Dec 2001

• Sauflon New Day (Methafilcon a) Soft (Hydrophilic) Daily Disposable Contact Lenses

  Class II

  FDA 510(k) K052832 Active Cleared 15 May 2006

• Sauflon Clariti with Tint, Sauflon Clariti Toric with Tint, Sauflon Clariti Multifocal with Tint

  Class II

  FDA 510(k) K133740 Active Cleared 5 Mar 2014

• Sauflon 55 UV Soft (Hydrophilic) Contact Lens

  Class II

  FDA 510(k) K013649 Active Cleared 26 Dec 2001

• Sauflon Clariti 1 Day (Somofilcon a) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker Open recall

  Class II

  FDA 510(k) K130331 Active Cleared 26 Jul 2013

See all devices from Sauflon Pharmaceuticals, Ltd. →

• What types of contact lenses is the Sauflon Aerotab Disinfecting System designed to disinfect, and how does it differ from other systems?

  The Sauflon Aerotab Disinfecting System is specifically designed for soft (hydrophilic) contact lenses, including clear, untinted lenses. Unlike some multi-purpose solutions that may require rinsing or additional steps, this system uses a tablet-based chemical disinfection that dissolves in solution within the lens case, ensuring microbial reduction while preserving lens integrity. It does not require external sterilization beyond the included tablet, making it a straightforward single-use process.

• Is the Sauflon Aerotab Disinfecting System intended for reuse, or is it meant to be discarded after each use?

  The system is designed for single-use only in a lens case. Each disinfecting tablet is meant to be used once, after which the case and any remaining solution should be discarded. This ensures proper hygiene and prevents cross-contamination between uses, aligning with standard ophthalmic disinfection practices.

• What components are included with the Sauflon Aerotab Disinfecting System, and how should it be stored?

  The system is supplied with a barrel lens case and unpreserved buffered saline solution, along with the disinfecting tablets. Storage instructions are not explicitly detailed in the data, but typical recommendations for such systems would involve keeping the tablets and case in a cool, dry place, away from direct sunlight or extreme temperatures, to maintain efficacy and sterility until use.

• How does the regulatory pathway for the Sauflon Aerotab Disinfecting System differ from other contact lens disinfection products?

  The Sauflon Aerotab Disinfecting System was cleared under the FDA’s 510(k) traditional review pathway and classified as a Class II device, indicating it was determined to be substantially equivalent to a legally marketed predicate device. This pathway involves a pre-market submission to demonstrate safety and effectiveness, distinguishing it from over-the-counter or prescription-only products without such clearance. The system falls under the ophthalmic specialty category and is regulated under FDA regulation number 886.5928.