Total clearances
4
2025-10-20 → 2026-09-10
Name variants in FDA filings: Sanhe Lefis Electronics Co., Ltd. / Sanhe LEFIS Electronics Co., Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| GEX |
Powered Laser Surgical Instrument |
Class II |
General, Plastic Surgery |
3 |
2026-09-10 |
| ONF |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
Class II |
General, Plastic Surgery |
1 |
2026-06-12 |
Filings
All 510(k) clearances (4)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-09-10 |
K261562 |
Diode Laser Therapy System |
GEX |
Class II |
General, Plastic Surgery |
| 2026-06-12 |
K261204 |
Intense Pulsed Light Therapy Device |
ONF |
Class II |
General, Plastic Surgery |
| 2025-12-19 |
K250998 |
CO2 Laser Therapy System (Model: LFS-D9U) |
GEX |
Class II |
General, Plastic Surgery |
| 2025-10-20 |
K252319 |
Q-Switched Nd: YAG Laser machine (LFS-C13U) |
GEX |
Class II |
General, Plastic Surgery |