MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
K-Number: K250195 · 2025-05-30
Device Summary
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. 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.
Other records listing Matelaser, Inc. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GEX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.