ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6— 510(k) K051922

Substantially Equivalent

Cynosure, Inc.

FDA 510(k) clearance K051922 for ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6, Substantially Equivalent on 2005-09-14. Applicant: Cynosure, Inc..

Clearance details

Applicant: Cynosure, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2005-07-15
Decision date: 2005-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chelmsford, MA, US

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Adverse events under product code ILY

product code ILY

Death: 3
Total: 3

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.