FDA 510(k)

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi

Numéro K : K222537 · 2022-10-14

DemandeurShenzhen Ishine Technology Company Limited

Date de décision2022-10-14

Code produitOHT

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ishine Technology Company Limited. It received FDA 510(k) clearance on 2022-10-14 under 510(k) number K222537. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi?

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi is a medical device that received FDA 510(k) clearance on 2022-10-14. The listed applicant is Shenzhen Ishine Technology Company Limited. The 510(k) number is K222537.

When did IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi receive FDA 510(k) clearance?

IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi received FDA 510(k) clearance on 2022-10-14, under 510(k) number K222537.

Who is the listed applicant for IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi?

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

What is the FDA product code for IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi?

The FDA product code for IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi is OHT.

Essais cliniques associés

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Dispositifs connexes (Code : OHT)

K261977Braun Aura 9 (6042)Cyden Limited K262524Sapphire 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.K260742Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)Shenzhen Ulike Smart Electronics Co., Ltd.

Source officielle

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