510(k) clearance

Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)

FDA 510(k) source

510(k) number

K262752

Applicant

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.

Decision date

Oct 23, 2026

Date received

Aug 3, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

OHS

Device type

Light Based Over The Counter Wrinkle Reduction

Device class

Class II

Regulation

21 CFR 878.4810

Advisory committee

General, Plastic Surgery

Statement or summary

Summary

Third party

N

Location

Shenzhen, CN