DUO
K-Number: K161565 · 2016-09-01
Decision Date2016-09-01
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DUO is a medical device manufactured by Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. It received FDA 510(k) clearance on 2016-09-01 under approval number K161565. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DUO?
DUO is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd. The 510(k) number is K161565.
When was DUO approved by the FDA?
DUO received FDA 510(k) clearance on 2016-09-01, under approval number K161565.
What company makes DUO?
DUO is manufactured by Stetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd.
What is the FDA product code for DUO?
The FDA product code for DUO is ONF.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.