K-number	K191068
Device name	Powersculp laser lipolysis system
Applicant	Wuhan Lotuxs Technology Co., Ltd.
Product code	PKT
Device class	Class II
Decision date	Jul 17, 2019
Decision	Substantially Equivalent
Regulation	878.5400

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Source

View the full FDA submission: accessdata.fda.gov

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Powersculp laser lipolysis system

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