Diode Laser Therapy System— 510(k) K261562
Substantially EquivalentSanhe LEFIS Electronics Co., Ltd.
FDA 510(k) clearance K261562 for Diode Laser Therapy System, Substantially Equivalent on 2026-09-10. Applicant: Sanhe LEFIS Electronics Co., Ltd.. Device class: 2.
Summary
The Diode Laser Therapy System is filed under GEX, powered laser surgical instruments. The name is generic, and the record doesn't give wavelengths or indications. Diode lasers in GEX are cleared for everything from hair removal to soft tissue surgery, so the name doesn't narrow it down.
Class II, 21 CFR 878.4810. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Sanhe LEFIS Electronics filed from Langfang, China. Review took 122 days (May 11 to September 10, 2026).
Clearance details
- Applicant
- Sanhe LEFIS Electronics 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
- Langfang, CN
Recent devices under product code GEX
view allMore clearances from Sanhe LEFIS Electronics 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.