K-number	K211402
Device name	Powersculp laser lipolysis system
Applicant	Lotuxs Medtech (Suzhou) Co., Ltd.
Product code	PKT
Device class	Class II
Decision date	Jul 30, 2021
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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