FDA 510(k)

IPLヘア除去装置、モデル：AI01、AI06、AI08、AI16、AI17

K番号: K221466 · 2022-08-12

申請者Shenzhen Century Dongyuan Technology CO , Ltd.

決定日2022-08-12

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: AI01, AI06, AI08, AI16, AI17 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K221466. 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: AI01, AI06, AI08, AI16, AI17?

IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. The 510(k) number is K221466.

When did IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 receive FDA 510(k) clearance?

IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 received FDA 510(k) clearance on 2022-08-12, under 510(k) number K221466.

Who is the listed applicant for IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17?

The FDA 510(k) record lists Shenzhen Century Dongyuan Technology 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, model: AI01, AI06, AI08, AI16, AI17?

The FDA product code for IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 is OHT.

申請者としてShenzhen Century Dongyuan Technology CO , Ltd.を記載するその他の記録

K212897IPLヘア除去装置、モデル：AI01

公式ソース

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