PKTClass II

Laser For Disruption Of Adipocyte Cells For Aesthetic Use

21 CFR 878.5400 / General, Plastic Surgery

PKT is the FDA product code for Laser For Disruption Of Adipocyte Cells For Aesthetic Use, a class II device type, regulated under 21 CFR 878.5400. FDA's definition for this code reads: "Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas". As of 2026-09-10, FDA records hold 19 510(k) clearances under this code, the most recent dated 2024-05-13, and no recalls.

Classification record

Product code: PKT
Device name: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
FDA definition: Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Regulation: 21 CFR 878.5400
Device class: Class II
Review panel: General, Plastic Surgery
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: Yes
Third party review eligible: No
Ingested clearances: 19
Ingested recalls: 0

Clearances, product code PKT

By decision year

19 clearances under product code PKT with a decision year between 2015 and 2024, 2019 the highest year at 3.

Show the numbers

510(k) clearances under FDA product code PKT by decision year
Year	Clearances
2015	2
2016	1
2017	2
2019	3
2020	2
2021	2
2022	2
2023	3
2024	2

Applicants with the most clearances

Product code PKT

Applicants holding the most 510(k) clearances under product code PKT
Applicant	Clearances
Cynosure, LLC	6
Dominion Aesthetic Technologies, Inc.	3
El.En S.p.A.	1
Hebei JT Medical Co.,Ltd	1
Hironic Co., Ltd.	1
Lightfective, Ltd.	1
Lotuxs Medtech (Suzhou) Co., Ltd.	1
Rohrer Aesthetics, Inc.	1
Shanghai Apolo Medical Technology Co.,Ltd.	1
Shanghai Bele Medical Technology Co.,Ltd	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order