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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 the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-07-17 under 510(k) 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. The listed applicant is Wuhan Lotuxs Technology Co., Ltd.. The 510(k) number is K191068.

When did Powersculp laser lipolysis system receive FDA 510(k) clearance?

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

Who is the listed applicant for Powersculp laser lipolysis system?

The FDA 510(k) record lists Wuhan Lotuxs Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Wuhan Lotuxs Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231910DermRays ReviveK232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)K230090Diode Laser Hair Removal

Related Devices (Code: PKT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.K233962ReBorn (1050nm)Lightfective , Ltd.K231971DEKA PHYSIQ 360El.En S.P.A.K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,LtdK222226EONDominion Aesthetic Technologies, Inc.K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd

Official Source

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

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