Identifiers
- 510(k) Number
- K230274 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medical Diode Laser (M2) is a versatile medical laser device that uses focused light energy for cutting, coagulation, and vaporization procedures. It offers multi-wavelength options including 808nm, 980nm, 1064nm, and 1470nm, with dual-wavelength simultaneous output capability. This device is suitable for various medical applications including dermatology, ENT, and gynecology procedures.
The M2 Medical Diode Laser is supplied as a complete medical laser system with high-power output capabilities. It is designed for use in clinical settings and supports a range of surgical procedures. The device has received FDA 510(k) clearance with product code GEX and is manufactured by Wuhan Pioon Technology Co., Ltd.
Frequently asked questions
What is the Medical Diode Laser M2 used for?
The Medical Diode Laser M2 is used for cutting, coagulation, and vaporization procedures in medical applications such as dermatology, ENT, and gynecology, utilizing focused light energy for precise tissue interaction.
What wavelengths does the Medical Diode Laser M2 support?
The Medical Diode Laser M2 supports multi-wavelength options including 808nm, 980nm, 1064nm, and 1470nm, with the capability for dual-wavelength simultaneous output to enhance procedural flexibility.
How is the Medical Diode Laser M2 supplied and configured?
The Medical Diode Laser M2 is supplied as a complete medical laser system with high-power output capabilities, designed for use in clinical settings to support a range of surgical procedures across multiple specialties.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pioon - Medical Diode Laser Manufacturer | Dental, Surgical, Aesthetic ..., M2 Medical Diode Laser- All Solutions in One - pioon.com, Wuhan Pioon Technology Co., Ltd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230274 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wuhan Pioon Technology Co., Ltd.
Sources (1)
- FDA 510(k) K230274 24 fields · synced Sep 27, 2026