SmoothSkin Pure Unplugged (SSB3)
K-Number: K240587 · 2024-03-29
ApplicantCyden Limited
Decision Date2024-03-29
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SmoothSkin Pure Unplugged (SSB3) is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2024-03-29 under approval number K240587. 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 Unplugged (SSB3)?
SmoothSkin Pure Unplugged (SSB3) is a medical device that received FDA 510(k) clearance on 2024-03-29. It is manufactured by Cyden Limited. The 510(k) number is K240587.
When was SmoothSkin Pure Unplugged (SSB3) approved by the FDA?
SmoothSkin Pure Unplugged (SSB3) received FDA 510(k) clearance on 2024-03-29, under approval number K240587.
What company makes SmoothSkin Pure Unplugged (SSB3)?
SmoothSkin Pure Unplugged (SSB3) is manufactured by Cyden Limited.
What is the FDA product code for SmoothSkin Pure Unplugged (SSB3)?
The FDA product code for SmoothSkin Pure Unplugged (SSB3) 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.