SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL— 510(k) K063161

Substantially Equivalent

Leonhard Lang GmbH

FDA 510(k) clearance K063161 for SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL, Substantially Equivalent on 2006-11-21. Applicant: Leonhard Lang GmbH.

Clearance details

Applicant: Leonhard Lang GmbH
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2006-10-17
Decision date: 2006-11-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Stillwater, MN, US

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Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.