Powersculp laser lipolysis system— 510(k) K211402

Name: FDA 510(k) clearance K211402
Creator: U.S. Food and Drug Administration
Published: 2021-07-30

Substantially Equivalent

Lotuxs Medtech (Suzhou) Co., Ltd.

FDA 510(k) clearance K211402 for Powersculp laser lipolysis system, Substantially Equivalent on 2021-07-30. Applicant: Lotuxs Medtech (Suzhou) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Lotuxs Medtech (Suzhou) Co., Ltd.
Product code: Code PKT
Device class: Class 2
Regulation: 21 CFR 878.5400
Advisory panel: General, Plastic Surgery
Date received: 2021-05-06
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, 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.