SmoothSkin Pure Switch (SSC1)
K-Number: K243362 · 2024-11-27
ApplicantCyden Limited
Decision Date2024-11-27
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
SmoothSkin Pure Switch (SSC1) is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2024-11-27 under approval number K243362. 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 Switch (SSC1)?
SmoothSkin Pure Switch (SSC1) is a medical device that received FDA 510(k) clearance on 2024-11-27. It is manufactured by Cyden Limited. The 510(k) number is K243362.
When was SmoothSkin Pure Switch (SSC1) approved by the FDA?
SmoothSkin Pure Switch (SSC1) received FDA 510(k) clearance on 2024-11-27, under approval number K243362.
What company makes SmoothSkin Pure Switch (SSC1)?
SmoothSkin Pure Switch (SSC1) is manufactured by Cyden Limited.
What is the FDA product code for SmoothSkin Pure Switch (SSC1)?
The FDA product code for SmoothSkin Pure Switch (SSC1) 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.