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FDA 510(k)

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)

K-Number: K240874 · 2024-05-28

ApplicantTheralaser Medtech (China) Co., Ltd.
Decision Date2024-05-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) is a medical device manufactured by Theralaser Medtech (China) Co., Ltd.. It received FDA 510(k) clearance on 2024-05-28 under approval number K240874. 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 Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)?

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) is a medical device that received FDA 510(k) clearance on 2024-05-28. It is manufactured by Theralaser Medtech (China) Co., Ltd.. The 510(k) number is K240874.

When was Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) approved by the FDA?

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) received FDA 510(k) clearance on 2024-05-28, under approval number K240874.

What company makes Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)?

Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) is manufactured by Theralaser Medtech (China) Co., Ltd..

What is the FDA product code for Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B)?

The FDA product code for Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) 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)

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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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