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FDA 510(k)

Braun Skin i.expert

K-Number: K230911 · 2023-04-27

ApplicantCyden Limited
Decision Date2023-04-27
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Braun Skin i.expert is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2023-04-27 under 510(k) number K230911. 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 Braun Skin i.expert?

Braun Skin i.expert is a medical device that received FDA 510(k) clearance on 2023-04-27. The listed applicant is Cyden Limited. The 510(k) number is K230911.

When did Braun Skin i.expert receive FDA 510(k) clearance?

Braun Skin i.expert received FDA 510(k) clearance on 2023-04-27, under 510(k) number K230911.

Who is the listed applicant for Braun Skin i.expert?

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 Braun Skin i.expert?

The FDA product code for Braun Skin i.expert 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)K213692SmoothSkin Pure Mini

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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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