FDA 510(k)

照射美學設備

K 號：K171835 · 2018-01-30

申請人Chongqing Peninsula Medical Technology Co., Ltd.

決定日期2018-01-30

產品代碼OAP

諮詢委員會PM

決定相當於

器材摘要

Irradiation Aesthetic Device is the device name listed in this FDA 510(k) record. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-01-30 under 510(k) number K171835. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Irradiation Aesthetic Device?

Irradiation Aesthetic Device is a medical device that received FDA 510(k) clearance on 2018-01-30. The listed applicant is Chongqing Peninsula Medical Technology Co., Ltd.. The 510(k) number is K171835.

When did Irradiation Aesthetic Device receive FDA 510(k) clearance?

Irradiation Aesthetic Device received FDA 510(k) clearance on 2018-01-30, under 510(k) number K171835.

Who is the listed applicant for Irradiation Aesthetic Device?

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

What is the FDA product code for Irradiation Aesthetic Device?

The FDA product code for Irradiation Aesthetic Device is OAP.

其他以 Chongqing Peninsula Medical Technology Co., Ltd. 為申請人之記錄

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K192642308nm 激光系統 K192552照射美容設備 K172273308nm 激光系統

相關器械（代碼：OAP）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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