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FDA 510(k)

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC

K-Number: K222862 · 2023-07-30

ApplicantLotuxs Medtech (Suzhou) Co., Ltd.
Decision Date2023-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC is a medical device manufactured by Lotuxs Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-07-30 under approval 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.

Frequently Asked Questions

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. It is manufactured by Lotuxs Medtech (Suzhou) Co., Ltd.. The 510(k) number is K222862.

When was SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC approved by the FDA?

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

What company makes SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC?

SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC is manufactured by Lotuxs Medtech (Suzhou) Co., Ltd..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Lotuxs Medtech (Suzhou) Co., Ltd.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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