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FDA 510(k)

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

K-Number: K243764 · 2025-05-08

ApplicantWuhan Pioon Technology Co., Ltd.
Decision Date2025-05-08
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) 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 2025-05-08 under 510(k) number K243764. 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 Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)?

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K243764.

When did Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) receive FDA 510(k) clearance?

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) received FDA 510(k) clearance on 2025-05-08, under 510(k) number K243764.

Who is the listed applicant for Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)?

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 (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)?

The FDA product code for Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) is NVK.

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.

K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)K240747Medical Diode Laser (M2-GK)K240644Medical Diode Laser (S1Pro)K240179Medical Diode Laser (Model: L2)K231548Medical Diode Laser, Model S1ProK230274Medical Diode Laser (M2)

View all 7 devices →

Related Devices (Code: NVK)

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.

K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy system family of the Dental diode laser ( ILaser III Pro)Shenzhen Soga Technology Co., Ltd.K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLCK250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.K230047Medical Diode Laser SystemsGigaalaser Company , Ltd.K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,LtdK232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.

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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