FDA 510(k)

MateLaser醫療二極雷射系統（ML-DLS-30）

K 號：K250731 · 2025-10-16

決定日期2025-10-16

產品代碼NVK

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

MateLaser Medical Diode Laser Systems (ML-DLS-30) is the device name listed in this FDA 510(k) record. The listed applicant is Matelaser, Inc.. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K250731. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MateLaser Medical Diode Laser Systems (ML-DLS-30)?

MateLaser Medical Diode Laser Systems (ML-DLS-30) is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Matelaser, Inc.. The 510(k) number is K250731.

When did MateLaser Medical Diode Laser Systems (ML-DLS-30) receive FDA 510(k) clearance?

MateLaser Medical Diode Laser Systems (ML-DLS-30) received FDA 510(k) clearance on 2025-10-16, under 510(k) number K250731.

Who is the listed applicant for MateLaser Medical Diode Laser Systems (ML-DLS-30)?

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 Diode Laser Systems (ML-DLS-30)?

The FDA product code for MateLaser Medical Diode Laser Systems (ML-DLS-30) is NVK.

其他以 Matelaser, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K250195MateLaser醫用雷射治療系統（ML-HIL-30、ML-HIL-60）

相關器械（代碼：NVK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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