Cleared Traditional

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

K243764 · Wuhan Pioon Technology Co., Ltd. · Dental

May 2025

Decision

153d

Days

Class 2

Risk

About This 510(k) Submission

K243764 is an FDA 510(k) clearance for the Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W), a Laser, Dental, Soft Tissue (Class II — Special Controls, product code NVK), submitted by Wuhan Pioon Technology Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on May 8, 2025, 153 days after receiving the submission on December 6, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K243764 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2024
Decision Date	May 08, 2025
Days to Decision	153 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	NVK — Laser, Dental, Soft Tissue
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Intended For The Incision, Excision, Cutting, Ablation, And Vaporization Of Soft Tissue In Oral And Maxillofacial Surgery And Dentistry.