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FDA 510(k)

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)

K-Number: K250195 · 2025-05-30

ApplicantMatelaser, Inc.
Decision Date2025-05-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) is a medical device manufactured by Matelaser, Inc.. It received FDA 510(k) clearance on 2025-05-30 under approval 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.

Frequently Asked Questions

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. It is manufactured by Matelaser, Inc.. The 510(k) number is K250195.

When was MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) approved by the FDA?

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

What company makes MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)?

MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) is manufactured by Matelaser, Inc..

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.

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Other Devices by Matelaser, Inc.

K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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