FDA.report

510(k) K240658

Device
1060nm laser body slimming machine
Applicant
Hebei JT Medical Co., Ltd.
510(k) number
K240658
Product code
PKT
Decision
Substantially Equivalent (SESE)
Decision date
2024-05-13
Date received
2024-03-08
Regulation
878.5400
Classification name
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Karen Liu
Address
C12 Hegu Industrial Park, Chaoyang Rd., Development Zone Zhuozhou City Hebei CN

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code PKT

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K222226EONDominion Aesthetic Technologies, Inc.2023-02-17
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K211681EONDominion Aesthetic Technologies, Inc.2022-03-30
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K211402Powersculp laser lipolysis systemLotuxs Medtech (Suzhou) Co., Ltd.2021-07-30
K192970SLIMUSHironic Co., Ltd.2020-12-01
K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.2020-09-10
K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.2019-07-17
K180511Eon FRDominion Aesthetic Technologies, Inc.2019-06-12
K182741SculpSureCynosure2019-01-03
K171992SculpSureCynosure, Inc.2017-09-26
K171111SculpsureCynosure, Inc.2017-06-13