Advanced Skin Renewing Device— 510(k) K182498

Name: FDA 510(k) clearance K182498
Creator: U.S. Food and Drug Administration
Published: 2018-11-30

Substantially Equivalent

Jiangsu Unimed Laser Technology Co., Ltd.

FDA 510(k) clearance K182498 for Advanced Skin Renewing Device, Substantially Equivalent on 2018-11-30. Applicant: Jiangsu Unimed Laser Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangsu Unimed Laser Technology Co., Ltd.
Product code: Product code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2018-09-12
Decision date: 2018-11-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jiangyin, CN

Download summary PDF View on FDA.gov ↗

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