FDA 510(k)

활모스 메디칼 레이저

K-번호: K231718 · 2023-08-18

신청자Allengers Global Healthcare Private Limited

결정일2023-08-18

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Holmium Medical Laser is the device name listed in this FDA 510(k) record. The listed applicant is Allengers Global Healthcare Private Limited. It received FDA 510(k) clearance on 2023-08-18 under 510(k) number K231718. 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 Holmium Medical Laser?

Holmium Medical Laser is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Allengers Global Healthcare Private Limited. The 510(k) number is K231718.

When did Holmium Medical Laser receive FDA 510(k) clearance?

Holmium Medical Laser received FDA 510(k) clearance on 2023-08-18, under 510(k) number K231718.

Who is the listed applicant for Holmium Medical Laser?

The FDA 510(k) record lists Allengers Global Healthcare Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Holmium Medical Laser?

The FDA product code for Holmium Medical Laser is GEX. This falls under the Gastroenterology category.

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