FDA 510(k)

SILKPRO 钛金二極雷射系統 SILKPRO-S20S-TWC

K 號：K222862 · 2023-07-30

決定日期2023-07-30

產品代碼GEX

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

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC 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 2023-07-30 under 510(k) number K222862. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC?

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC is a medical device that received FDA 510(k) clearance on 2023-07-30. The listed applicant is Lotuxs Medtech (Suzhou) Co., Ltd.. The 510(k) number is K222862.

When did SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC receive FDA 510(k) clearance?

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC received FDA 510(k) clearance on 2023-07-30, under 510(k) number K222862.

Who is the listed applicant for SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC?

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 SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC?

The FDA product code for SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC is GEX. This falls under the Gastroenterology category.

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

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相關器械（代碼：GEX）

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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