FDA 510(k)

マットレーザー医療レーザー治療システム（ML-HIL-30、ML-HIL-60）

K番号: K250195 · 2025-05-30

決定日2025-05-30

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてMatelaser, Inc.を記載するその他の記録

K250731マットレーザー医療用レーザーディオードシステム（ML-DLS-30）

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