ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED— 510(k) K914726

Substantially Equivalent

Ion Laser Technology

FDA 510(k) clearance K914726 for ILT CO2 SURGICAL LASER FOR ORAL SOFT TISSUE PROCED, Substantially Equivalent on 1991-12-17. Applicant: Ion Laser Technology.

Clearance details

Applicant: Ion Laser Technology
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1991-10-21
Decision date: 1991-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, 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.