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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 a medical device manufactured by Wuhan Pioon Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-08 under approval 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. It is manufactured by Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K243764.

When was Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) approved by the FDA?

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 approval number K243764.

What company makes 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 manufactured by Wuhan Pioon Technology Co., Ltd..

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.

Related Clinical Trials

NCT07607028 Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth COMPLETED NCT07593508 Diode Laser-Assisted Direct Pulp Capping Trial COMPLETED NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07099352 Efficacy of of Acupuncture Laser Therapy on Hemodialysis Patients NOT_YET_RECRUITING NCT06960161 Exploring the Use of Phototherapy to Improve CPAP Compliance RECRUITING NCT07278999 Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus. RECRUITING

Other Devices by Wuhan Pioon Technology Co., Ltd.

K231548Medical Diode Laser, Model S1Pro K230274Medical Diode Laser (M2) K240747Medical Diode Laser (M2-GK) K240644Medical Diode Laser (S1Pro) K240179Medical Diode Laser (Model: L2) K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)

View all 7 devices →

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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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