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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 the device name listed in this FDA 510(k) record. The listed applicant is Lotuxs Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) 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. The listed applicant is Lotuxs Medtech (Suzhou) Co., Ltd.. The 510(k) number is K211402.

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

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

Who is the listed applicant for Powersculp laser lipolysis system?

The FDA 510(k) record lists Lotuxs Medtech (Suzhou) 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 Lotuxs Medtech (Suzhou) 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.

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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.

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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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