SmoothSkin BARE+
K-Number: K192010 · 2019-09-24
ApplicantCyden Limited
Decision Date2019-09-24
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SmoothSkin BARE+ is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2019-09-24 under approval number K192010. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SmoothSkin BARE+?
SmoothSkin BARE+ is a medical device that received FDA 510(k) clearance on 2019-09-24. It is manufactured by Cyden Limited. The 510(k) number is K192010.
When was SmoothSkin BARE+ approved by the FDA?
SmoothSkin BARE+ received FDA 510(k) clearance on 2019-09-24, under approval number K192010.
What company makes SmoothSkin BARE+?
SmoothSkin BARE+ is manufactured by Cyden Limited.
What is the FDA product code for SmoothSkin BARE+?
The FDA product code for SmoothSkin BARE+ is OHT.
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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.