Sanhe?Lefis?Electronics?Co., Ltd. is one of 2114 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Sanhe?Lefis?Electronics?Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Diode Laser Therapy System, Intense Pulsed Light Therapy Device, CO2 Laser Therapy System (Model: LFS-D9U)
4
Total
4
Cleared
0
Denied
Sanhe?Lefis?Electronics?Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Langfang, CN.
Latest FDA clearance: Sep 2026. Active since 2025. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Sanhe?Lefis?Electronics?Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Sanhe Lefis Electronics Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Sanhe?Lefis?Electronics?Co., Ltd.
4 devices
Cleared
Sep 10, 2026
Diode Laser Therapy System
General & Plastic Surgery
122d
Cleared
Jun 12, 2026
Intense Pulsed Light Therapy Device
General & Plastic Surgery
60d
Cleared
Dec 19, 2025
CO2 Laser Therapy System (Model: LFS-D9U)
General & Plastic Surgery
262d
Cleared
Oct 20, 2025
Q-Switched Nd: YAG Laser machine (LFS-C13U)
General & Plastic Surgery
87d