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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 the device name listed in this FDA 510(k) record. The listed applicant is Shandong Moonlight Electronics Tech Co., Ltd.. It received FDA 510(k) clearance on 2025-05-12 under 510(k) 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. The listed applicant is Shandong Moonlight Electronics Tech Co., Ltd.. The 510(k) number is K250431.

When did Medical Diode Laser Hair Removal System (MNLT-D1) receive FDA 510(k) clearance?

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

Who is the listed applicant for Medical Diode Laser Hair Removal System (MNLT-D1)?

The FDA 510(k) record lists Shandong Moonlight Electronics Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

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.

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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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