PIOON

GUDID 06974624062109

The medical diode laser(UTU3-G7B) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.The device utilizes a solid state diode as laser energy source.The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.The UTU3-G7B employ the diodes with wavelengths of 980nm, 650nm and 450nm,it emits laser output energy in the infrared, red and blue spectra respectively.

Wuhan Pioon Technology Co., Ltd.

General/multiple surgical diode laser system

• Primary Device ID: 06974624062109
• NIH Device Record Key: 4222ecb4-db5d-40c1-aa36-e1400f3bb9bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIOON
• Version Model Number: UTU3-G7B
• Company DUNS: 553185386
• Company Name: Wuhan Pioon Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +862781783687
• Email: lynn@pioon.com
• Phone: +862781783687
• Email: lynn@pioon.com
• Phone: +862781783687
• Email: lynn@pioon.com
• Phone: +862781783687
• Email: lynn@pioon.com
• Phone: +862781783687
• Email: lynn@pioon.com
• Phone: +862781783687
• Email: lynn@pioon.com
• Phone: +862781783687
• Email: lynn@pioon.com
• Phone: +862781783687
• Email: lynn@pioon.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974624062109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243764

FDA Product Code

• EEG: Heat Source For Bleaching Teeth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-15
• Device Publish Date: 2025-07-07

On-Brand Devices [PIOON]

• 06974624060129: 1470nm Medical Diode Laser
• 06974624062109: The medical diode laser(UTU3-G7B) is a surgical and therapeutic device designated for a wide var
• 06974624062116: The medical diode laser(UTU3-G7W) is a surgical and therapeutic device designated for a wide var