DERMA K LASER SYSTEM— 510(k) K972872

Substantially Equivalent

Esc Medical Systems , Ltd.

FDA 510(k) clearance K972872 for DERMA K LASER SYSTEM, Substantially Equivalent on 1997-10-28. Applicant: Esc Medical Systems , Ltd..

Clearance details

Applicant: Esc Medical Systems , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1997-08-04
Decision date: 1997-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

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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.