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FDA 510(k)

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)

K-Number: K233756 · 2024-02-02

ApplicantRhein Laser Technologies Co., Ltd.
Decision Date2024-02-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is a medical device manufactured by Rhein Laser Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-02-02 under approval number K233756. 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 Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)?

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is a medical device that received FDA 510(k) clearance on 2024-02-02. It is manufactured by Rhein Laser Technologies Co., Ltd.. The 510(k) number is K233756.

When was Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) approved by the FDA?

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) received FDA 510(k) clearance on 2024-02-02, under approval number K233756.

What company makes Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)?

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is manufactured by Rhein Laser Technologies Co., Ltd..

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

The FDA product code for Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT07607028 Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth COMPLETED NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07593508 Diode Laser-Assisted Direct Pulp Capping Trial COMPLETED NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED

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 Rhein Laser Technologies Co., Ltd.

K242293Medical Thulium Fiber Laser Systems (UroFiber 60Q) K233757TitanPico Laser Workstation (PICO-450)

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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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