iPulse SmoothSkin BARE Hair Removal Device
K-Number: K163552 · 2017-03-03
ApplicantCyden Limited
Decision Date2017-03-03
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
iPulse SmoothSkin BARE Hair Removal Device is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2017-03-03 under approval number K163552. 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 iPulse SmoothSkin BARE Hair Removal Device?
iPulse SmoothSkin BARE Hair Removal Device is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Cyden Limited. The 510(k) number is K163552.
When was iPulse SmoothSkin BARE Hair Removal Device approved by the FDA?
iPulse SmoothSkin BARE Hair Removal Device received FDA 510(k) clearance on 2017-03-03, under approval number K163552.
What company makes iPulse SmoothSkin BARE Hair Removal Device?
iPulse SmoothSkin BARE Hair Removal Device is manufactured by Cyden Limited.
What is the FDA product code for iPulse SmoothSkin BARE Hair Removal Device?
The FDA product code for iPulse SmoothSkin BARE Hair Removal Device 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.