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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.

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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.

K261975Braun Aura 7 (6041)K261977Braun Aura 9 (6042)K243362SmoothSkin Pure Switch (SSC1)K240587SmoothSkin Pure Unplugged (SSB3)K233782SmoothSkin Pure Adapt (SSG3)K230911Braun Skin i.expert

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Related Devices (Code: OHT)

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.

K261975Braun Aura 7 (6041)CyDen LimitedK261977Braun Aura 9 (6042)Cyden LimitedK262524Sapphire Cooling IPL Hair Removal Device (Ice 2.0, Ice 2.1, Ice 2.2, Ice 2.0B, Ice 2.1B, Ice 2.2B)ONE BEAUTY Technology Co., Ltd.K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)Shenzhen Ulike Smart Electronics Co., Ltd.K260594IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM)Shenzhen Xiazhifeng Electronic 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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