SmoothSkin Pure Mini
K-Number: K213692 · 2022-01-26
ApplicantCyden Limited
Decision Date2022-01-26
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SmoothSkin Pure Mini is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2022-01-26 under approval number K213692. 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 Mini?
SmoothSkin Pure Mini is a medical device that received FDA 510(k) clearance on 2022-01-26. It is manufactured by Cyden Limited. The 510(k) number is K213692.
When was SmoothSkin Pure Mini approved by the FDA?
SmoothSkin Pure Mini received FDA 510(k) clearance on 2022-01-26, under approval number K213692.
What company makes SmoothSkin Pure Mini?
SmoothSkin Pure Mini is manufactured by Cyden Limited.
What is the FDA product code for SmoothSkin Pure Mini?
The FDA product code for SmoothSkin Pure Mini 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.