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FDA 510(k)

Powersculp laser lipolysis system

K-Number: K211402 · 2021-07-30

ApplicantLotuxs Medtech (Suzhou) Co., Ltd.
Decision Date2021-07-30
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Powersculp laser lipolysis system is a medical device manufactured by Lotuxs Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-07-30 under approval number K211402. 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 2021-07-30. It is manufactured by Lotuxs Medtech (Suzhou) Co., Ltd.. The 510(k) number is K211402.

When was Powersculp laser lipolysis system approved by the FDA?

Powersculp laser lipolysis system received FDA 510(k) clearance on 2021-07-30, under approval number K211402.

What company makes Powersculp laser lipolysis system?

Powersculp laser lipolysis system is manufactured by Lotuxs Medtech (Suzhou) 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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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Lotuxs Medtech (Suzhou) Co., Ltd.

K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC

Related Devices (Code: PKT)

K160470SculpSureCynosure, Inc. K171992SculpSureCynosure, Inc. K171111SculpsureCynosure, Inc. K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. K180511Eon FRDominion Aesthetic Technologies, Inc. K182741SculpSureCynosure

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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