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FDA 510(k)

Medical Diode Laser Hair Removal System (MNLT-D1)

K-Number: K250431 · 2025-05-12

ApplicantShandong Moonlight Electronics Tech Co., Ltd.
Decision Date2025-05-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser Hair Removal System (MNLT-D1) is a medical device manufactured by Shandong Moonlight Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-05-12 under approval number K250431. 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 Medical Diode Laser Hair Removal System (MNLT-D1)?

Medical Diode Laser Hair Removal System (MNLT-D1) is a medical device that received FDA 510(k) clearance on 2025-05-12. It is manufactured by Shandong Moonlight Electronics Tech Co., Ltd.. The 510(k) number is K250431.

When was Medical Diode Laser Hair Removal System (MNLT-D1) approved by the FDA?

Medical Diode Laser Hair Removal System (MNLT-D1) received FDA 510(k) clearance on 2025-05-12, under approval number K250431.

What company makes Medical Diode Laser Hair Removal System (MNLT-D1)?

Medical Diode Laser Hair Removal System (MNLT-D1) is manufactured by Shandong Moonlight Electronics Tech Co., Ltd..

What is the FDA product code for Medical Diode Laser Hair Removal System (MNLT-D1)?

The FDA product code for Medical Diode Laser Hair Removal System (MNLT-D1) is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

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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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