CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR.— 510(k) K915583

Substantially Equivalent

Heraeus Lasersonics, Inc.

FDA 510(k) clearance K915583 for CO2 LASER AND WAVEGUIDE DELIVERY SYSTEMS FOR THOR., Substantially Equivalent on 1992-03-27. Applicant: Heraeus Lasersonics, Inc..

Clearance details

Applicant: Heraeus Lasersonics, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1991-12-13
Decision date: 1992-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, 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.