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FDA 510(k)

Powersculp laser lipolysis system

K-Number: K191068 · 2019-07-17

ApplicantWuhan Lotuxs Technology Co., Ltd.
Decision Date2019-07-17
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Powersculp laser lipolysis system is a medical device manufactured by Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-07-17 under approval number K191068. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powersculp laser lipolysis system?

Powersculp laser lipolysis system is a medical device that received FDA 510(k) clearance on 2019-07-17. It is manufactured by Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K191068.

When was Powersculp laser lipolysis system approved by the FDA?

Powersculp laser lipolysis system received FDA 510(k) clearance on 2019-07-17, under approval number K191068.

What company makes Powersculp laser lipolysis system?

Powersculp laser lipolysis system is manufactured by Wuhan Lotuxs Technology Co., Ltd..

What is the FDA product code for Powersculp laser lipolysis system?

The FDA product code for Powersculp laser lipolysis system is PKT.

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Other Devices by Wuhan Lotuxs Technology Co., Ltd.

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Related Devices (Code: PKT)

K160470SculpSureCynosure, Inc. K171992SculpSureCynosure, Inc. K171111SculpsureCynosure, Inc. K180511Eon FRDominion Aesthetic Technologies, Inc. K182741SculpSureCynosure K192970SLIMUSHironic Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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