VASSEN COLOR— 510(k) K141699

Substantially Equivalent

Vassen Co., Ltd.

FDA 510(k) clearance K141699 for VASSEN COLOR, Substantially Equivalent on 2014-10-07. Applicant: Vassen Co., Ltd..

Clearance details

Applicant: Vassen Co., Ltd.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2014-06-24
Decision date: 2014-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hillsboro, OR, US

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

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.