Data / Medical devices / China / Sanhe LEFIS Electronics Co.,Ltd
Sanhe LEFIS Electronics Co.,Ltd: FDA-registered device maker in langfang Hebei, China, 5 510(k) clearances
Sanhe LEFIS Electronics Co.,Ltd is registered with the FDA (registration 3016453004) in langfang Hebei, China. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 10, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016453004
- Address
- Building 11 #1-101, Phase 1, Zhongnan High tech Yanjiao Science and Technology Innovation Smart Valley Indust, langfang Hebei, China, 065201
- Owner or operator
- Sanhe LEFIS Electronics Co.,Ltd (10062323)
- Roles
- Manufacturer
- First device listed
- January 12, 2020
- Registered through
- 2026
- Brand names listed
- CO2 Laser Therapy System, Diode Laser Therapy System, Diode Laser Therapy System LFS-K13 Pro S 5D, Intense Pulsed Light Treatment device, Q Switched Nd: YAG Laser machine
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 10, 2026 | K261562 | Diode Laser Therapy System | GEX | Substantially Equivalent | Sanhe LEFIS Electronics Co., Ltd. | accessdata.fda.gov |
| June 12, 2026 | K261204 | Intense Pulsed Light Therapy Device | ONF | Substantially Equivalent | Sanhe LEFIS Electronics Co., Ltd. | accessdata.fda.gov |
| December 19, 2025 | K250998 | CO2 Laser Therapy System (Model: LFS-D9U) | GEX | Substantially Equivalent | Sanhe Lefis Electronics Co., Ltd. | accessdata.fda.gov |
| October 20, 2025 | K252319 | Q-Switched Nd: YAG Laser machine (LFS-C13U) | GEX | Substantially Equivalent | Sanhe Lefis Electronics Co., Ltd. | accessdata.fda.gov |
| December 13, 2019 | K192569 | Diode Laser Therapy System | GEX | Substantially Equivalent | San HE Lefis Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Updated September 10, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.