iPulse SmoothSkin Gold Hair Removal Device
K-Number: K160968 · 2016-04-14
ApplicantCyden Limited
Decision Date2016-04-14
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
iPulse SmoothSkin Gold Hair Removal Device is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2016-04-14 under approval number K160968. 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 Gold Hair Removal Device?
iPulse SmoothSkin Gold Hair Removal Device is a medical device that received FDA 510(k) clearance on 2016-04-14. It is manufactured by Cyden Limited. The 510(k) number is K160968.
When was iPulse SmoothSkin Gold Hair Removal Device approved by the FDA?
iPulse SmoothSkin Gold Hair Removal Device received FDA 510(k) clearance on 2016-04-14, under approval number K160968.
What company makes iPulse SmoothSkin Gold Hair Removal Device?
iPulse SmoothSkin Gold Hair Removal Device is manufactured by Cyden Limited.
What is the FDA product code for iPulse SmoothSkin Gold Hair Removal Device?
The FDA product code for iPulse SmoothSkin Gold 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.