SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM— 510(k) K952554

Substantially Equivalent

Schwartz Electro-Optics, Inc.

FDA 510(k) clearance K952554 for SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM, Substantially Equivalent on 1995-08-28. Applicant: Schwartz Electro-Optics, Inc..

Clearance details

Applicant: Schwartz Electro-Optics, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1995-06-02
Decision date: 1995-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, 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.