FDA 510(k)

IPLヘア除去装置、モデル：skn001、skn005、skn006、skn002、RoseSkinCo Lumi

K番号: K222537 · 2022-10-14

申請者Shenzhen Ishine Technology Company Limited

決定日2022-10-14

製品コードOHT

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

公式ソース

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IPLヘア除去装置、モデル：skn001、skn005、skn006、skn002、RoseSkinCo Lumi

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：OHT）

公式ソース