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FDA 510(k)

SmoothSkin BARE+

K-Number: K192010 · 2019-09-24

ApplicantCyden Limited
Decision Date2019-09-24
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SmoothSkin BARE+ is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2019-09-24 under 510(k) number K192010. 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 BARE+?

SmoothSkin BARE+ is a medical device that received FDA 510(k) clearance on 2019-09-24. The listed applicant is Cyden Limited. The 510(k) number is K192010.

When did SmoothSkin BARE+ receive FDA 510(k) clearance?

SmoothSkin BARE+ received FDA 510(k) clearance on 2019-09-24, under 510(k) number K192010.

Who is the listed applicant for SmoothSkin BARE+?

The FDA 510(k) record lists Cyden Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmoothSkin BARE+?

The FDA product code for SmoothSkin BARE+ is OHT.

Other records listing Cyden Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243362SmoothSkin Pure Switch (SSC1)K240587SmoothSkin Pure Unplugged (SSB3)K233782SmoothSkin Pure Adapt (SSG3)K230911Braun Skin i.expertK213692SmoothSkin Pure MiniK211994Braun Silk.expert Mini

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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.

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