IPL Cooling Hair Removal Device— 510(k) K232845

Clearance details

Applicant

Shenzhen Siken 3D Technology Development Co., Ltd.

Product code

Code OHT

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2023-09-14

Decision date

2023-11-14

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shenzhen, CN

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