FDA 510(k)

二極雷射體雕塑系統

K 號：K231131 · 2023-06-22

申請人Shanghai Bele Medical Technology Co.,Ltd

決定日期2023-06-22

產品代碼PKT

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Diode Laser Body Sculpture Systems is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K231131. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Diode Laser Body Sculpture Systems?

Diode Laser Body Sculpture Systems is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. The 510(k) number is K231131.

When did Diode Laser Body Sculpture Systems receive FDA 510(k) clearance?

Diode Laser Body Sculpture Systems received FDA 510(k) clearance on 2023-06-22, under 510(k) number K231131.

Who is the listed applicant for Diode Laser Body Sculpture Systems?

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

What is the FDA product code for Diode Laser Body Sculpture Systems?

The FDA product code for Diode Laser Body Sculpture Systems is PKT.

其他以 Shanghai Bele Medical Technology Co.,Ltd 為申請人之記錄

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。

K240474多功能平台系統 (BL-M10)K240386皮秒Nd:YAG雷射系統（BL-C10）

相關器械（代碼：PKT）

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。

K2406581060nm 激光體雕身機Hebei JT Medical Co., Ltd.K233962ReBorn (1050nm)Lightfective , Ltd.K231971DEKA PHYSIQ 360El.En S.P.A.K222226EONDominion Aesthetic Technologies, Inc.K222265迪奧斯庫普特Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd K211681EONDominion Aesthetic Technologies, Inc.

官方來源

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