MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST— 510(k) K924258

Substantially Equivalent

Ceram Optec, Inc.

FDA 510(k) clearance K924258 for MEGABEAM RADIAL EMIT SHAPE FIBER OPTIC DELIV SYST, Substantially Equivalent on 1994-03-09. Applicant: Ceram Optec, Inc..

Clearance details

Applicant: Ceram Optec, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1992-08-24
Decision date: 1994-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.