FREEDOM ND: YAG LASER SYSTEM— 510(k) K113843

Name: FDA 510(k) clearance K113843
Creator: U.S. Food and Drug Administration
Published: 2012-09-27

Substantially Equivalent

Lutronic Corporation

FDA 510(k) clearance K113843 for FREEDOM ND: YAG LASER SYSTEM, Substantially Equivalent on 2012-09-27. Applicant: Lutronic Corporation. Device class: 2.

Clearance details

Applicant: Lutronic Corporation
Product code: Code PDZ
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2011-12-28
Decision date: 2012-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Trevose, PA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.