WAVELIGHT FS200 PATIENT INTERFACE 1505— 510(k) K121031

Substantially Equivalent

Alcon Research, Ltd.

FDA 510(k) clearance K121031 for WAVELIGHT FS200 PATIENT INTERFACE 1505, Substantially Equivalent on 2012-06-21. Applicant: Alcon Research, Ltd..

Clearance details

Applicant: Alcon Research, Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2012-04-05
Decision date: 2012-06-21
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Fort Worth, TX, US

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Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.