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

Name: FDA 510(k) clearance K962592
Creator: U.S. Food and Drug Administration
Published: 1996-09-23

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. Device class: 2.

Clearance details

Applicant: Alcon Laboratories
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
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

Download summary PDF View on FDA.gov ↗

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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.