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Panels › General, Plastic Surgery › Product code PKT · Class 2

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Regulation 878.5400

0510(k)s in 12 months (19 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in PKT

Company510(k)sRecalls
Cynosure60
Dominion Aesthetic Technologies, Inc.30
El.En S.P.A.10
Hebei JT Medical Co., Ltd.10
Hironic Co., Ltd.10
Lightfective , Ltd.10
Lotuxs Medtech (Suzhou) Co., Ltd.10
Rohrer Aesthetics, LLC10
Shanghai Apolo Medical Technology Co., Ltd.10
Shanghai Bele Medical Technology Co.,Ltd10
Decided510(k)Device and applicantCode
May 13, 2024K2406581060nm laser body slimming machine
Hebei JT Medical Co., Ltd., CN
PKT
Apr 16, 2024K233962ReBorn (1050nm)
Lightfective , Ltd., IL
PKT
Sep 26, 2023K231971DEKA PHYSIQ 360
El.En S.P.A., IT
PKT
Jun 22, 2023K231131Diode Laser Body Sculpture Systems
Shanghai Bele Medical Technology Co.,Ltd, CN
PKT
Feb 17, 2023K222226EON
Dominion Aesthetic Technologies, Inc.
PKT
Sep 23, 2022K222265Diosculpt
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd, CN
PKT
Mar 30, 2022K211681EON
Dominion Aesthetic Technologies, Inc.
PKT
Nov 9, 2021K212331BodySculp
Rohrer Aesthetics, LLC
PKT
Jul 30, 2021K211402Powersculp laser lipolysis system
Lotuxs Medtech (Suzhou) Co., Ltd., CN
PKT
Dec 1, 2020K192970SLIMUS
Hironic Co., Ltd., KR
PKT
Sep 10, 2020K201731Diode Laser Body Sculpture System
Shanghai Apolo Medical Technology Co., Ltd., CN
PKT
Jul 17, 2019K191068Powersculp laser lipolysis system
Wuhan Lotuxs Technology Co., Ltd., CN
PKT
Jun 12, 2019K180511Eon FR
Dominion Aesthetic Technologies, Inc.
PKT
Jan 3, 2019K182741SculpSure
Cynosure
PKT
Sep 26, 2017K171992SculpSure
Cynosure, Inc.
PKT
Jun 13, 2017K171111Sculpsure
Cynosure, Inc.
PKT
Jul 21, 2016K160470SculpSure
Cynosure, Inc.
PKT
Jul 1, 2015K150724SculpSure
Cynosure, Inc.
PKT
May 15, 2015K150230SculpSure
Cynosure, Inc.
PKT

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