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FDA 510(k)

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)

K-Number: K242197 · 2024-10-17

ApplicantShenzhen Huaruibo Electric Appliances Co., Ltd.
Decision Date2024-10-17
Product CodeOHT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Huaruibo Electric Appliances Co., Ltd.. It received FDA 510(k) clearance on 2024-10-17 under 510(k) number K242197. 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 IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is a medical device that received FDA 510(k) clearance on 2024-10-17. The listed applicant is Shenzhen Huaruibo Electric Appliances Co., Ltd.. The 510(k) number is K242197.

When did IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) receive FDA 510(k) clearance?

IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) received FDA 510(k) clearance on 2024-10-17, under 510(k) number K242197.

Who is the listed applicant for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

The FDA 510(k) record lists Shenzhen Huaruibo Electric Appliances Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max)?

The FDA product code for IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) is OHT.

Related Clinical Trials

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.

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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.

K262352IPL Hair Removal Device (AHR01, R3C16-G Pro1, AHR02, AHR03, R4820, R6715, L3B02, JR20, R6312, R6202)Shenzhen Jianchao Intelligent Technology Co., Ltd.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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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