Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Product Code: PKT

General & Plastic Surgery Medical Laser Products

Definition: Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.5400


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as PKT

5869Laser For Disruption Of Adipocyte Cells For Aesthetic UseLow Level Laser System For Aesthetic Use

Total Product Life Cycle (TPLC) Devices

5869Laser For Disruption Of Adipocyte Cells For Aesthetic UseLow Level Laser System For Aesthetic Use

Pre-market Notifications for PKT

K222265DiosculptShanghai Wonderful Opto-Electrics Tech. Co., Ltd.
K211402Powersculp Laser Lipolysis SystemLotuxs Medtech (Suzhou) Co., Ltd.
K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.
K191068Powersculp Laser Lipolysis SystemWuhan Lotuxs Technology Co., Ltd.
K182741SculpSureCynosure
K171992SculpsureCynosure, Inc
K171111SculpsureCynosure, Inc
K160470SculpSureCYNOSURE, INC.
K150724SculpSureCYNOSURE, INC.
K150230SculpSureCYNOSURE, INC.

Global Unique Device Identification Database

00841494107925Laser for disruption of adipocyte cells for aesthetic use
00841494106775Laser for disruption of adipocyte cells for aesthetic use
00841494107994Laser for disruption of adipocyte cells for aesthetic use
00841494107963Laser for disruption of adipocyte cells for aesthetic use
00841494107956Laser for disruption of adipocyte cells for aesthetic use
00841494107468Laser for disruption of adipocyte cells for aesthetic use
00841494106867Laser for disruption of adipocyte cells for aesthetic use
00841494100049Laser for disruption of adipocyte cells for aesthetic use
00841494100032Laser for disruption of adipocyte cells for aesthetic use
06970745918516Laser For Disruption Of Adipocyte Cells For Aesthetic Use
07290016541724Laser For Disruption Of Adipocyte Cells For Aesthetic Use
07290016541717Laser For Disruption Of Adipocyte Cells For Aesthetic Use
07290016541625Laser For Disruption Of Adipocyte Cells For Aesthetic Use
07290016541564Laser For Disruption Of Adipocyte Cells For Aesthetic Use
07290016541632Laser For Disruption Of Adipocyte Cells For Aesthetic Use

Maude Adverse Events

SCULPSURECYNOSURE LLC2020-03-23
SCULPSURECYNOSURE LLC2020-03-11
SCULPSURECYNOSURE LLC2020-02-06
SCULPSURECYNOSURE LLC2019-11-22
SCULPSURECYNOSURE LLC2019-09-24
SCULPSURECYNOSURE LLC2019-09-13
ICONCYNOSURE LLC2019-07-12
SCULPSURECYNOSURE, LLC2019-07-05
SCULPSURECYNOSURE, LLC2019-07-05
SCULPSURECYNOSURE, LLC2019-07-05
SCULPSURECYNOSURE LLC2019-05-07
SCULPSURECYNOSURE INC.2019-03-14
SCULPSURECYNOSURE INC.2019-03-14
ICONCYNOSURE INC.2019-02-22
SCULPSURECYNOSURE INC.2019-02-05
SCULPSURECYNOSURE INC.2018-11-01
SCULPSURECYNOSURE INC.2018-11-01
SCULPSURECYNOSURE INC.2018-11-01
CYNOSURE SCULPSURECYNOSURE, INC. / HOLOGIC, INC.2018-10-03
SCULPSURECYNOSURE INC.2018-09-26
SCULPSURECYNOSURE INC.2018-09-26
SCULPSURECYNOSURE INC.2018-09-12
SCULPSURECYNOSURE INC.2018-09-12
SCULPSURECYNOSURE INC.2018-09-11
SCULPSURECYNOSURE INC.2018-07-13
SCULPSURECYNOSURE INC.2018-07-06
SCULPSURECYNOSURE2018-06-19
SCULPSURECYNOSURE INC.2018-06-15
SCULPSURECYNOSURE INC.2018-05-29
SCULPSURECYNOSURE INC2018-01-12
SCULPSURECYNOSURE INC2018-01-05
SCULPSURECYNOSURE INC2017-11-17
SCULPSURECYNOSURE INC2017-08-25
SCULPSURECYNOSURE INC2017-08-17
SCULPSURECYNOSURE INC2017-08-02
SCULPSURECYNOSURE INC2017-06-28
SCULPSURECYNOSURE2017-06-22
SCULPSURECYNOSURE INC2017-05-25
SCULPSURECYNOSURE INC2017-04-07
SCULPSURECYNOSURE, INC2017-03-02
SCULPSURECYNOSURE2017-02-01
SCULPSURECYNOSURE INC2016-12-15
SCULPSURECYNOSURE INC2016-11-09
SCULPSURECYNOSURE INC2016-10-28
SCULPSURECYNOSURE INC2016-10-07
SCULPSURECYNOSURE INC2016-09-09
SCULPSURECYNOSURE INC2016-08-25
SCULPSURECYNOSURE INC2016-06-15
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