FDA 510(k)

1060nm 激光體雕身機

K 號：K240658 · 2024-05-13

決定日期2024-05-13

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

1060nm laser body slimming machine is the device name listed in this FDA 510(k) record. The listed applicant is Hebei JT Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K240658. 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 1060nm laser body slimming machine?

1060nm laser body slimming machine is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Hebei JT Medical Co., Ltd.. The 510(k) number is K240658.

When did 1060nm laser body slimming machine receive FDA 510(k) clearance?

1060nm laser body slimming machine received FDA 510(k) clearance on 2024-05-13, under 510(k) number K240658.

Who is the listed applicant for 1060nm laser body slimming machine?

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

What is the FDA product code for 1060nm laser body slimming machine?

The FDA product code for 1060nm laser body slimming machine is PKT.

其他以 Hebei JT Medical 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。

K250722奈秒YAG雷射治療系統（QN-1）K232181體型雕塑機（型號：CS2、CS3、CS5、CS7、CS8、CS11、CS13）

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。

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官方來源

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