Identity
- Trade Name
- PIOON FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- 1940nm Medical Diode Laser FDA UDI
- Model / Reference
- M2 FDA UDI
- Description
- 1940nm Medical Diode Laser FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974624060112 FDA UDI
- 510(k) Number
- K230274 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Pioon by Wuhan Pioon Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K230274 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Wuhan Pioon Technology Co., Ltd.
Sources (1)
- FDA UDI 14e22ef4-bbb0-457d-8212-5acf67b64c2a 37 fields · synced May 30, 2026