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FDA 510(k)

Medical Diode Laser (Model: L2)

K-Number: K240179 · 2024-03-21

ApplicantWuhan Pioon Technology Co., Ltd.
Decision Date2024-03-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser (Model: L2) is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Pioon Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-03-21 under 510(k) number K240179. 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 (Model: L2)?

Medical Diode Laser (Model: L2) is a medical device that received FDA 510(k) clearance on 2024-03-21. The listed applicant is Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K240179.

When did Medical Diode Laser (Model: L2) receive FDA 510(k) clearance?

Medical Diode Laser (Model: L2) received FDA 510(k) clearance on 2024-03-21, under 510(k) number K240179.

Who is the listed applicant for Medical Diode Laser (Model: L2)?

The FDA 510(k) record lists Wuhan Pioon Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Diode Laser (Model: L2)?

The FDA product code for Medical Diode Laser (Model: L2) is GEX. This falls under the Gastroenterology category.

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Other records listing Wuhan Pioon Technology Co., Ltd. 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.

K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)K240747Medical Diode Laser (M2-GK)K240644Medical Diode Laser (S1Pro)K231548Medical Diode Laser, Model S1ProK230274Medical Diode Laser (M2)

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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

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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