ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING— 510(k) K964222

Substantially Equivalent

Paladin Medical, Inc.

FDA 510(k) clearance K964222 for ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING, Substantially Equivalent on 1996-12-20. Applicant: Paladin Medical, Inc..

Clearance details

Applicant: Paladin Medical, Inc.
Product code: Code LYL
Advisory panel: Ophthalmic
Date received: 1996-10-22
Decision date: 1996-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stillwater, MN, 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.