MDS-90 ARGON DYE LASER FOR DERMATOLOGY— 510(k) K872578

Substantially Equivalent

Meditec of America

FDA 510(k) clearance K872578 for MDS-90 ARGON DYE LASER FOR DERMATOLOGY, Substantially Equivalent on 1987-10-01. Applicant: Meditec of America.

Clearance details

Applicant: Meditec of America
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 1987-06-30
Decision date: 1987-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bethesda, MD, 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.