OPTI PADS— 510(k) K950940

Substantially Equivalent

Karlen Mfg., Inc.

FDA 510(k) clearance K950940 for OPTI PADS, Substantially Equivalent on 1995-06-26. Applicant: Karlen Mfg., Inc..

Clearance details

Applicant: Karlen Mfg., Inc.
Product code: Code LYL
Advisory panel: Ophthalmic
Date received: 1995-02-27
Decision date: 1995-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Charles, MI, US

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Adverse events under product code LYL

product code LYL

Other: 1
Total: 1

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.