SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES— 510(k) K991125

Substantially Equivalent

Sauflon Pharmaceuticals, Ltd.

FDA 510(k) clearance K991125 for SAUFLON AEROTAB DISINFECTING SYSTEM FOR THE DISINFECTION OF SOFT (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 1999-09-14. Applicant: Sauflon Pharmaceuticals, Ltd..

Clearance details

Applicant: Sauflon Pharmaceuticals, Ltd.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 1999-04-02
Decision date: 1999-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

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Adverse events under product code LPN

product code LPN

Injury: 333
Other: 8
Total: 341

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.