FDA 510(k)

IPL毛髪除去装置モデル：スキンエキスパートプロIPL 008、スキンエキスパートプロIPL 008S

K番号: K231215 · 2023-06-26

決定日2023-06-26

製品コードOHT

諮問委員会SU

決定Substantially Equivalent

医療機器の概要

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Qizhe Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K231215. 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: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S?

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is Zhongshan Qizhe Technology Co., Ltd.. The 510(k) number is K231215.

When did IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S receive FDA 510(k) clearance?

IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S received FDA 510(k) clearance on 2023-06-26, under 510(k) number K231215.

Who is the listed applicant for IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S?

The FDA 510(k) record lists Zhongshan Qizhe 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: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S?

The FDA product code for IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S is OHT.

公式ソース

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IPL毛髪除去装置モデル：スキンエキスパートプロIPL 008、スキンエキスパートプロIPL 008S

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