510(k) clearance

Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)

FDA 510(k) source

510(k) number

K261572

Applicant

Keyue (Hangzhou) Medical Information Technology Co., Ltd.

Decision date

Oct 13, 2026

Date received

May 12, 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

Statement

Third party

N

Location

Hangzhou, CN