AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM— 510(k) K961710

Substantially Equivalent

Applied Optronics Corp.

FDA 510(k) clearance K961710 for AOC MEDICAL SYSTEM MODEL PHASE II 25 SURGICAL DIODE LASER SYSTEM, Substantially Equivalent on 1996-11-01. Applicant: Applied Optronics Corp..

Clearance details

Applicant: Applied Optronics Corp.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1996-05-02
Decision date: 1996-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Plainfield, NJ, 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.