DUO— 510(k) K161565

Name: FDA 510(k) clearance K161565
Creator: U.S. Food and Drug Administration
Published: 2016-09-01

Substantially Equivalent

Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd

FDA 510(k) clearance K161565 for DUO, Substantially Equivalent on 2016-09-01. Applicant: Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. Device class: 2.

Clearance details

Applicant: Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2016-06-06
Decision date: 2016-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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