Manufacturer and brand owner in Langfang, Hebei, China. 2 device types, 1 product catalogued, 3 clearances.
Sanhe Lefis Electronics Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument, Powered Light Based Non-Laser Surgical Instrument With Thermal Effect. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
Registration
FDA registration record for Sanhe Lefis Electronics Co., Ltd. | Registered name | Sanhe LEFIS Electronics Co.,Ltd |
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016453004 |
| FEI number | 3016453004 |
| DUNS | 550747317 |
| Establishment type | Manufacturer |
Chinese Registration
Chinese company register details for Sanhe Lefis Electronics Co., Ltd. | Chinese legal name | 三河市乐菲电子产品有限公司 |
| Unified social credit code | 91131082358537865K |
| Source | NMPA UDI database |
Location
Address of Sanhe Lefis Electronics Co., Ltd. | City | Langfang |
| Province | Hebei |
| Address | Building 11 #1-101, Phase 1, Zhongnan High tech Yanjiao Science and Technology Innovation Smart Valley Indust |
| Postal code | 065201 |
| Country | China |
Clearances
3 clearances name Sanhe Lefis Electronics Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
From the Company
Published by the company on its own website, not by the FDA.
Information published by Sanhe Lefis Electronics Co., Ltd. | Founded | 2015 |
| Main products | Diode Laser Hair Removal, HIFU Machines, RF Microneedling Machines, CO₂ Fractional Laser, Picosecond Laser |
| Certifications | ISO13485 |
| Export markets | Philippines, Japan, Poland, Russia, 50+ countries via distributors |
| OEM and ODM | Offered |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.