FDA Product Code PKT: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Laser Intended For The Disruption Of Adipocyte Cells Indicated For Body Contouring Or Reduction In Circumference Of Body Areas.
Leading manufacturers include Dominion Aesthetic Technologies, Inc., Cynosure, Inc. and Cynosure.
19
Total
19
Cleared
144d
Avg days
2015
Since
Declining activity -
0 submissions in the last 2 years
vs 6 in the prior period
FDA 510(k) Cleared Laser For Disruption Of Adipocyte Cells For Aesthetic Use Devices (Product Code PKT)
19 devices
Cleared
May 13, 2024
1060nm laser body slimming machine
Hebei JT Medical Co., Ltd.
General & Plastic Surgery
66d
Cleared
Apr 16, 2024
ReBorn (1050nm)
Lightfective , Ltd.
General & Plastic Surgery
123d
Cleared
Sep 26, 2023
DEKA PHYSIQ 360
El.En S.P.A.
General & Plastic Surgery
85d
Cleared
Jun 22, 2023
Diode Laser Body Sculpture Systems
Shanghai Bele Medical Technology Co.,Ltd
General & Plastic Surgery
62d
Cleared
Feb 17, 2023
EON
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery
207d
Cleared
Sep 23, 2022
Diosculpt
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
General & Plastic Surgery
57d
Cleared
Mar 30, 2022
EON
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery
302d
Cleared
Nov 09, 2021
BodySculp
Rohrer Aesthetics, LLC
General & Plastic Surgery
105d
Cleared
Jul 30, 2021
Powersculp laser lipolysis system
Lotuxs Medtech (Suzhou) Co., Ltd.
General & Plastic Surgery
85d
Cleared
Dec 01, 2020
SLIMUS
Hironic Co., Ltd.
General & Plastic Surgery
405d
Cleared
Sep 10, 2020
Diode Laser Body Sculpture System
Shanghai Apolo Medical Technology Co., Ltd.
General & Plastic Surgery
78d
Cleared
Jul 17, 2019
Powersculp laser lipolysis system
Wuhan Lotuxs Technology Co., Ltd.
General & Plastic Surgery
86d
Cleared
Jun 12, 2019
Eon FR
Dominion Aesthetic Technologies, Inc.
General & Plastic Surgery
470d
Cleared
Jan 03, 2019
SculpSure
Cynosure
General & Plastic Surgery
97d
Cleared
Sep 26, 2017
SculpSure
Cynosure, Inc.
General & Plastic Surgery
85d
Cleared
Jun 13, 2017
Sculpsure
Cynosure, Inc.
General & Plastic Surgery
60d
About Product Code PKT - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code PKT since 2015, with 19 receiving FDA clearance (average review time: 144 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 6 in the prior period.