FDA 510(k)

마틀라스 메디칼 레이저 테라피 시스템 (ML-HIL-30, ML-HIL-60)

K-번호: K250195 · 2025-05-30

결정일2025-05-30

제품 코드GEX

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

결정대체적으로 동일

기기 요약

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) is the device name listed in this FDA 510(k) record. The listed applicant is Matelaser, Inc.. It received FDA 510(k) clearance on 2025-05-30 under 510(k) number K250195. 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 MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)?

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) is a medical device that received FDA 510(k) clearance on 2025-05-30. The listed applicant is Matelaser, Inc.. The 510(k) number is K250195.

When did MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) receive FDA 510(k) clearance?

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) received FDA 510(k) clearance on 2025-05-30, under 510(k) number K250195.

Who is the listed applicant for MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)?

The FDA 510(k) record lists Matelaser, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)?

The FDA product code for MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) is GEX. This falls under the Gastroenterology category.

Matelaser, Inc.를 신청인으로 등재한 기타 기록

K250731마틀라스 메디칼 디오드 레이저 시스템 (ML-DLS-30)

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