510(k) clearance

1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)

FDA 510(k) source

510(k) number

K261821

Applicant

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Decision date

Aug 27, 2026

Date received

Jun 1, 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

Zhengzhou, CN