Intense Pulsed Light Treatment System— 510(k) K192521

Name: FDA 510(k) clearance K192521
Creator: U.S. Food and Drug Administration
Published: 2019-12-06

Substantially Equivalent

Shangdong Huamei Technology Co., Ltd.

FDA 510(k) clearance K192521 for Intense Pulsed Light Treatment System, Substantially Equivalent on 2019-12-06. Applicant: Shangdong Huamei Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shangdong Huamei Technology Co., Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2019-09-13
Decision date: 2019-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Weifang, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.