SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION— 510(k) K974485

Substantially Equivalent

Szabocsik and Assoc.

FDA 510(k) clearance K974485 for SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION, Substantially Equivalent on 1998-02-24. Applicant: Szabocsik and Assoc..

Clearance details

Applicant: Szabocsik and Assoc.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 1997-11-26
Decision date: 1998-02-24
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.