SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS— 510(k) K963229

Substantially Equivalent

Sharplan Lasers, Inc.

FDA 510(k) clearance K963229 for SHARPLAN MODELS 20C, 30C, AND 40C CO2 LASERS, Substantially Equivalent on 1996-11-05. Applicant: Sharplan Lasers, Inc..

Clearance details

Applicant: Sharplan Lasers, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1996-08-19
Decision date: 1996-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warwick, RI, 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.