Powersculp laser lipolysis system— 510(k) K211402

Substantially Equivalent

Lotuxs Medtech (Suzhou) Co., Ltd.

FDA 510(k) clearance K211402 for Powersculp laser lipolysis system, Substantially Equivalent on 2021-07-30. Applicant: Lotuxs Medtech (Suzhou) Co., Ltd..

Clearance details

Applicant: Lotuxs Medtech (Suzhou) Co., Ltd.
Product code: Code PKT
Advisory panel: General, Plastic Surgery
Date received: 2021-05-06
Decision date: 2021-07-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

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