FDA 510(k)

ダイヤモンドエアプラス（UI04A、UI04B、UI04C、UI04M、UI04G、UI04W）

K番号: K243030 · 2024-10-25

決定日2024-10-25

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

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is the device name listed in this FDA 510(k) record. The listed applicant is Ulike Co., Ltd.. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K243030. 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 Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Ulike Co., Ltd.. The 510(k) number is K243030.

When did Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) receive FDA 510(k) clearance?

Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) received FDA 510(k) clearance on 2024-10-25, under 510(k) number K243030.

Who is the listed applicant for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?

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

What is the FDA product code for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W)?

The FDA product code for Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) is OHT.

申請者としてUlike Co., Ltd.を記載するその他の記録

K221553ダイヤモンドエアプラス（UI04A、UI04B、UI04C）K213558IPLヘア除去装置

公式ソース

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