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FDA 510(k)

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

K-Number: K250731 · 2025-10-16

ApplicantMatelaser, Inc.
Decision Date2025-10-16
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Matelaser, Inc.. The 510(k) number is K250731.

When was MateLaser Medical Diode Laser Systems (ML-DLS-30) approved by the FDA?

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

What company makes MateLaser Medical Diode Laser Systems (ML-DLS-30)?

MateLaser Medical Diode Laser Systems (ML-DLS-30) is manufactured by Matelaser, Inc..

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.

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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42037982 Ethical, legal, and social implications of AI-enabled digital therapeutics: A comparative analysis of risk-based regulatory frameworks in the European Union and Japan. Digital health (2026) PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026)

Other Devices by Matelaser, Inc.

K250195MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)

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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.

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