Pioon

FDA UDI

Class I (US FDA UDI)

by Wuhan Pioon Technology Co., Ltd.

Identity

Trade Name: PIOON FDA UDI
Generic Name: General/multiple surgical diode laser system FDA UDI
Device Name: The medical diode laser(UTU3-G7W) 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-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm,it emits laser output energy in the infrared, red and blue spectra respectively. FDA UDI
Model / Reference: UTU3-G7W FDA UDI
Description: The medical diode laser(UTU3-G7W) 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-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm,it emits laser output energy in the infrared, red and blue spectra respectively. FDA UDI

Identifiers

Primary DI / UDI-DI: 06974624062116 FDA UDI
FDA Product Code: EEG FDA UDI
NVK FDA UDI
GEX FDA UDI
ILY FDA UDI
GMDN Term: General/multiple surgical diode laser system FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.6475 FDA UDI
878.4810 FDA UDI
890.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: General/multiple surgical diode laser system

Pioon by Wuhan Pioon Technology Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Wuhan Pioon Technology Co., Ltd.

Sources (1)

FDA UDI 0c9d78d4-6e89-4308-a990-0ae5d2eb96da 34 fields · synced Jun 1, 2026