FDA 510(k)

MateLaser 医用二极管激光系统（ML-DLS-30）

K号: K250731 · 2025-10-16

决定日期2025-10-16

产品代码NVK

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决定实质等同

器械摘要

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.

常见问题

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.

列明Matelaser, Inc.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K250195MateLaser 医用激光治疗系统（ML-HIL-30，ML-HIL-60）

相关器械（代码：NVK）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253309SOGA激光治疗系统Aurora手柄系列（Aurora-S）；SOGA激光治疗系统牙科二极管激光（ILaser III Pro）系列Shenzhen Soga Technology Co., Ltd.K260765Gemini NOVA 810+980 软组织激光器Azena Medical, LLC K243764医疗二极管激光器（UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W）Wuhan Pioon Technology Co., Ltd.K230047医疗二极管激光系统Gigaalaser Company , Ltd.K232885Dawn 二极管激光系统Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.

官方来源

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