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FDA 510(k)

Medical Diode Laser Hair Removal System

K-Number: K200525 · 2020-05-27

ApplicantWeifang Mingliang Electronics Co., Ltd.
Decision Date2020-05-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser Hair Removal System is a medical device manufactured by Weifang Mingliang Electronics Co., Ltd.. It received FDA 510(k) clearance on 2020-05-27 under approval number K200525. 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?

Medical Diode Laser Hair Removal System is a medical device that received FDA 510(k) clearance on 2020-05-27. It is manufactured by Weifang Mingliang Electronics Co., Ltd.. The 510(k) number is K200525.

When was Medical Diode Laser Hair Removal System approved by the FDA?

Medical Diode Laser Hair Removal System received FDA 510(k) clearance on 2020-05-27, under approval number K200525.

What company makes Medical Diode Laser Hair Removal System?

Medical Diode Laser Hair Removal System is manufactured by Weifang Mingliang Electronics Co., Ltd..

What is the FDA product code for Medical Diode Laser Hair Removal System?

The FDA product code for Medical Diode Laser Hair Removal System 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)

Other Devices by Weifang Mingliang Electronics Co., Ltd.

K242183Fractional CO2 Laser Therapy System (EXFU CO2) K260307Diode Laser Therapy Systems (V19)

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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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