# Sanhe LEFIS Electronics Co.,Ltd (manufacturer, langfang Hebei, CN): 2 new FDA device listings, incl. powered light based non-laser surgical instrument with thermal effect

**Score:** 70/100

| Field | Value |
|---|---|
| Establishment | Sanhe LEFIS Electronics Co.,Ltd |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | langfang Hebei, CN |
| New listings | 2 |
| Devices | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect; Powered Laser Surgical Instrument |
| Product codes | ONF, GEX |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery |
| Brand names | Intense Pulsed Light Treatment device; Diode Laser Therapy System LFS-K13 Pro S 5D |
| First new listing | 2026-07-21 |
| Latest new listing | 2026-09-23 |
| FDA registration number | 3016453004 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.