510(k) clearance

Diode Laser Therapy System

FDA 510(k) source

510(k) number

K261562

Applicant

Sanhe LEFIS Electronics Co., Ltd.

Decision date

Sep 10, 2026

Date received

May 11, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

GEX

Device type

Powered Laser Surgical Instrument

Device class

Class II

Regulation

21 CFR 878.4810

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Langfang, CN