FDA 510(k)

IPLヘア除去デバイスモデル：MLY-T069

K番号: K230473 · 2023-06-15

決定日2023-06-15

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 Models: MLY-T069 is the device name listed in this FDA 510(k) record. The listed applicant is Miley Technology (Hebei) Co., Ltd.. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K230473. 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 Models: MLY-T069?

IPL Hair Removal Device Models: MLY-T069 is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is Miley Technology (Hebei) Co., Ltd.. The 510(k) number is K230473.

When did IPL Hair Removal Device Models: MLY-T069 receive FDA 510(k) clearance?

IPL Hair Removal Device Models: MLY-T069 received FDA 510(k) clearance on 2023-06-15, under 510(k) number K230473.

Who is the listed applicant for IPL Hair Removal Device Models: MLY-T069?

The FDA 510(k) record lists Miley Technology (Hebei) 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 Models: MLY-T069?

The FDA product code for IPL Hair Removal Device Models: MLY-T069 is OHT.

申請者としてMiley Technology (Hebei) Co., Ltd.を記載するその他の記録

K251914IPL毛髪除去装置（MLY-M011）；IPL毛髪除去装置（MLY-M012）；IPL毛髪除去装置（MLY-M013）；IPL毛髪除去装置（MLY-M015）；IPL毛髪除去装置（MLY-T001）；IPL毛髪除去装置（MLY-T002）

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