Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)— 510(k) K262426
Substantially EquivalentWuhan Pioon Technology Co., Ltd.
FDA 510(k) clearance K262426 for Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75), Substantially Equivalent on 2026-09-10. Applicant: Wuhan Pioon Technology Co., Ltd.. Device class: 2.
Summary
The Medical Diode Laser covers four models: S1Pro+, S1Pro K15, S1Pro N6, and S1Pro N75. It's filed under GEX, powered laser surgical instruments. The record doesn't give wavelengths or indications, and GEX diode clearances range from hair removal to soft tissue surgery.
Class II, 21 CFR 878.4810. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Wuhan Pioon Technology filed from Wuhan, China. Review took 56 days (July 16 to September 10, 2026), quick for a four-model laser filing.
Clearance details
- Applicant
- Wuhan Pioon Technology Co., Ltd.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wuhan, CN
Recent devices under product code GEX
view allMore clearances from Wuhan Pioon Technology Co., Ltd.
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.