FDA 510(k)

아르테미스 다이오드 레이저 시스템 (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)

K-번호: K233756 · 2024-02-02

결정일2024-02-02

제품 코드GEX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) is the device name listed in this FDA 510(k) record. The listed applicant is Rhein Laser Technologies Co., Ltd.. It received FDA 510(k) clearance on 2024-02-02 under 510(k) 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.

자주 묻는 질문

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. The listed applicant is Rhein Laser Technologies Co., Ltd.. The 510(k) number is K233756.

When did Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) receive FDA 510(k) clearance?

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

Who is the listed applicant for Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755)?

The FDA 510(k) record lists Rhein Laser Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Rhein Laser Technologies Co., Ltd.를 신청인으로 등재한 기타 기록

K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)K242293Medical Thulium Fiber Laser Systems (UroFiber 60Q)K233757TitanPico Laser Workstation (PICO-450)

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