FDA 510(k)

Powersculp 激光溶脂系統

K 號：K211402 · 2021-07-30

決定日期2021-07-30

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

Powersculp laser lipolysis system is the device name listed in this FDA 510(k) record. The listed applicant is Lotuxs Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K211402. 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 Powersculp laser lipolysis system?

Powersculp laser lipolysis system is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Lotuxs Medtech (Suzhou) Co., Ltd.. The 510(k) number is K211402.

When did Powersculp laser lipolysis system receive FDA 510(k) clearance?

Powersculp laser lipolysis system received FDA 510(k) clearance on 2021-07-30, under 510(k) number K211402.

Who is the listed applicant for Powersculp laser lipolysis system?

The FDA 510(k) record lists Lotuxs Medtech (Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Powersculp laser lipolysis system?

The FDA product code for Powersculp laser lipolysis system is PKT.

其他以 Lotuxs Medtech (Suzhou) Co., Ltd. 為申請人之記錄

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官方來源

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