FDA UDI
Not in Commercial Distribution
🇺🇸 United States
PIOON
DI: 06974624062116
·
Model: UTU3-G7W
·
Wuhan Pioon Technology Co., Ltd.
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PIOON
- Primary DI
- 06974624062116
- Version / Model
- UTU3-G7W
- Company Name
- Wuhan Pioon Technology Co., Ltd.
- Labeler DUNS
- 553185386
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-08
- Public Version
- 2
- Public Version Date
- 2026-03-27
- Public Version Status
- Update
- Public Device Record Key
- 0c9d78d4-6e89-4308-a990-0ae5d2eb96da
- Distribution End Date
- 2025-07-08
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | Dental | 872.6475 | 1 |
| NVK | Laser, Dental, Soft Tissue | General, Plastic Surgery | 878.4810 | 2 |
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60341 | General/multiple surgical diode laser system | An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to incise, excise, ablate, vaporize and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06974624062116 | GS1 |
Customer Contacts
- Phone
- +862781783687
- [email protected]