SmoothSkin Pure
K-Number: K200184 · 2020-02-21
ApplicantCyden Limited
Decision Date2020-02-21
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SmoothSkin Pure is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2020-02-21 under approval number K200184. 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 Pure?
SmoothSkin Pure is a medical device that received FDA 510(k) clearance on 2020-02-21. It is manufactured by Cyden Limited. The 510(k) number is K200184.
When was SmoothSkin Pure approved by the FDA?
SmoothSkin Pure received FDA 510(k) clearance on 2020-02-21, under approval number K200184.
What company makes SmoothSkin Pure?
SmoothSkin Pure is manufactured by Cyden Limited.
What is the FDA product code for SmoothSkin Pure?
The FDA product code for SmoothSkin Pure 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.