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PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use Class II

FDA Device Classification

Classification Details

Product Code
PKT
Device Class
Class II
Regulation Number
878.5400
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240658hebei jt medical co1060nm laser body slimming machineMay 13, 2024
K233962lightfectiveReBorn (1050nm)April 16, 2024
K231971el.enDEKA PHYSIQ 360September 26, 2023
K231131shanghai bele medical technology coDiode Laser Body Sculpture SystemsJune 22, 2023
K222226dominion aesthetic technologiesEONFebruary 17, 2023
K222265shanghai wonderful opto-electrics tech.coDiosculptSeptember 23, 2022
K211681dominion aesthetic technologiesEONMarch 30, 2022
K212331rohrer aestheticsBodySculpNovember 9, 2021
K211402lotuxs medtech (suzhou) coPowersculp laser lipolysis systemJuly 30, 2021
K192970hironic coSLIMUSDecember 1, 2020
K201731shanghai apolo medical technology coDiode Laser Body Sculpture SystemSeptember 10, 2020
K191068wuhan lotuxs technology coPowersculp laser lipolysis systemJuly 17, 2019
K180511dominion aesthetic technologiesEon FRJune 12, 2019
K182741cynosureSculpSureJanuary 3, 2019
K171992cynosureSculpSureSeptember 26, 2017
K171111cynosureSculpsureJune 13, 2017
K160470cynosureSculpSureJuly 21, 2016
K150724cynosureSculpSureJuly 1, 2015
K150230cynosureSculpSureMay 15, 2015