Manufacturer
Wuhan Pioon Technology Co., Ltd.Medical Diode Laser (M2)
Wuhan Pioon Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K230274
- Device name
- Medical Diode Laser (M2)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-02-01
- Decision date
- 2023-03-31
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
Medical Diode Laser is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
Intended Use
Medical Diode Laser is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
Device Description
The predicated device is Fotona SkyPulse Laser Platform (K193656), a 1940nm Diode Laser with same intended use as the subject device. Energy source: Solid state diode. Configuration: Main Unit, Foot Control. Laser Wavelength: 1940nm. Laser Classification: Class IV. Power range: Up to 7.5W. Pulse width: CW or 10 ms – 10 s. Repetition rate: CW or up to 100 Hz. Delivery system: Fiber delivery. User interface: Touch screen control. Safety feature: Complied with IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+A1:2020, IEC 60601-2-22:2019, IEC 60825-1:2014.
Summary parsed at:2026-06-01 05:32:30 UTC
Predicate devices
1SkyPulse
K230274 references 1 predicate/reference device
Cited as predicate
1Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
1 submission cite K230274 as a predicate