HILT FAMILY LASER: HILT I, HILT II, HILT III— 510(k) K051537

Substantially Equivalent

Cynosure, Inc.

FDA 510(k) clearance K051537 for HILT FAMILY LASER: HILT I, HILT II, HILT III, Substantially Equivalent on 2005-09-26. Applicant: Cynosure, Inc..

Clearance details

Applicant: Cynosure, Inc.
Product code: Code ILY
Advisory panel: Physical Medicine
Date received: 2005-06-10
Decision date: 2005-09-26
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.