FDA 510(k)

家庭用毛髪除去機器、モデル：Precise Touch Pro

K番号: K213830 · 2022-02-01

決定日2022-02-01

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

Home use hair removal device, model: Precise Touch Pro is the device name listed in this FDA 510(k) record. The listed applicant is Iluminage Beauty Co., Limited. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K213830. 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 Home use hair removal device, model: Precise Touch Pro?

Home use hair removal device, model: Precise Touch Pro is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Iluminage Beauty Co., Limited. The 510(k) number is K213830.

When did Home use hair removal device, model: Precise Touch Pro receive FDA 510(k) clearance?

Home use hair removal device, model: Precise Touch Pro received FDA 510(k) clearance on 2022-02-01, under 510(k) number K213830.

Who is the listed applicant for Home use hair removal device, model: Precise Touch Pro?

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

What is the FDA product code for Home use hair removal device, model: Precise Touch Pro?

The FDA product code for Home use hair removal device, model: Precise Touch Pro is OHT.

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家庭用毛髪除去機器、モデル：Precise Touch Pro

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）

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