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FDA 510(k)

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

K-Number: K162231 · 2016-11-16

ApplicantCyden Limited
Decision Date2016-11-16
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert is a medical device manufactured by Cyden Limited. It received FDA 510(k) clearance on 2016-11-16 under approval number K162231. 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, Venus Silk.expert?

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert is a medical device that received FDA 510(k) clearance on 2016-11-16. It is manufactured by Cyden Limited. The 510(k) number is K162231.

When was iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert approved by the FDA?

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert received FDA 510(k) clearance on 2016-11-16, under approval number K162231.

What company makes iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert?

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert is manufactured by Cyden Limited.

What is the FDA product code for iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert?

The FDA product code for iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert is OHT.

Related Clinical Trials

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Related PubMed Literature

PMID: 40608192 "Appropriateness" of Clinical Data Under Regulation (EU) 2017/745- A Case Study and Survey. Therapeutic innovation & regulatory science (2025)

Other Devices by Cyden Limited

K160968iPulse SmoothSkin Gold Hair Removal Device K170734Venus Silk.expert K163552iPulse SmoothSkin BARE Hair Removal Device K192010SmoothSkin BARE+ K190366BRAUN Silk Expert Pro 3 K190354BRAUN Silk.expert Pro 5

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Related Devices (Code: OHT)

K161089sensiLight MiniEl Global Trade, Ltd. K160968iPulse SmoothSkin Gold Hair Removal DeviceCyden Limited K172181micro IPLEl Global Trade, Ltd. K171433Silk'n InfinityHome Skinovations , Ltd. K170269Hee HR MiniOriental Inspiration Limited K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.

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.

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