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 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| lynn@pioon.com | |
| Phone | +862781783687 |
| 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 |
Trademark Results [PIOON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PIOON 79275398 not registered Live/Pending |
WUHAN PIOON TECHNOLOGY CO., LTD. 2019-10-12 |
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