OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS— 510(k) K962592

Substantially Equivalent

Alcon Laboratories

FDA 510(k) clearance K962592 for OPHTHALAS 532 SOLID STATE PHOTOCOAGULATOR, OR EQUIVALENT LASER SYSTEMS, Substantially Equivalent on 1996-09-23. Applicant: Alcon Laboratories.

Clearance details

Applicant: Alcon Laboratories
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1996-07-02
Decision date: 1996-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
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.