Powersculp laser lipolysis system— 510(k) K191068

Name: FDA 510(k) clearance K191068
Creator: U.S. Food and Drug Administration
Published: 2019-07-17

Substantially Equivalent

Wuhan Lotuxs Technology Co., Ltd.

FDA 510(k) clearance K191068 for Powersculp laser lipolysis system, Substantially Equivalent on 2019-07-17. Applicant: Wuhan Lotuxs Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wuhan Lotuxs Technology Co., Ltd.
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2019-04-22
Decision date: 2019-07-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Lake High-Tech Development Zone, Wu, 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.