MACH LED SC— 510(k) K093009

Substantially Equivalent

Dr. Mach GmbH & Co. KG

FDA 510(k) clearance K093009 for MACH LED SC, Substantially Equivalent on 2010-04-01. Applicant: Dr. Mach GmbH & Co. KG.

Clearance details

Applicant: Dr. Mach GmbH & Co. KG
Product code: Code FSY
Advisory panel: General, Plastic Surgery
Date received: 2009-09-29
Decision date: 2010-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ebersberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FSY

product code FSY

Malfunction: 2,759
Other: 1
Total: 2,760

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.