OPELASER PRO II AND THE OPELASER LITE II— 510(k) K120932

Substantially Equivalent

The Yoshida Dental Mfg. Co., Ltd.

FDA 510(k) clearance K120932 for OPELASER PRO II AND THE OPELASER LITE II, Substantially Equivalent on 2012-12-07. Applicant: The Yoshida Dental Mfg. Co., Ltd..

Clearance details

Applicant: The Yoshida Dental Mfg. Co., Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2012-03-28
Decision date: 2012-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, 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.