FDA 510(k)

SILKPRO钛激光系统 SILKPRO-S20S-TWC

K号: K222862 · 2023-07-30

决定日期2023-07-30

产品代码GEX

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决定实质等同

器械摘要

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.

常见问题

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.

列明Lotuxs Medtech (Suzhou) Co., Ltd.为申报人的其他记录

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