OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES— 510(k) K000998

Substantially Equivalent

Optisonic, Inc.

FDA 510(k) clearance K000998 for OPTION CARE SYSTEM FOR THE CLEANING AND DISINFECTING OF SOFT (HYDROPHILIC) CONTACT LENSES, Substantially Equivalent on 2000-06-05. Applicant: Optisonic, Inc..

Clearance details

Applicant: Optisonic, Inc.
Product code: Code LPN
Advisory panel: Ophthalmic
Date received: 2000-03-23
Decision date: 2000-06-05
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.