FDA product code PKT: Laser For Disruption Of Adipocyte Cells For Aesthetic Use
PKT is the FDA product code for laser for disruption of adipocyte cells for aesthetic use. It is a Class II device, regulated under 21 CFR 878.5400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 19 510(k) submissions under PKT, 7 in the last five years, from 13 different applicants. The average 510(k) review took 144 days (median 97); 94 days on average over the last three years.
Definition
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Classification
| Field | Value |
|---|---|
| Device name | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Device class | Class II |
| Regulation | 21 CFR 878.5400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| GMP exempt | Yes |
510(k) clearances per year for PKT
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 72 |
| 2019 | 3 | 218 |
| 2020 | 2 | 242 |
| 2021 | 2 | 95 |
| 2022 | 2 | 180 |
| 2023 | 3 | 118 |
| 2024 | 2 | 94 |
Compare with all 510(k) review times · Search every PKT clearance
Top PKT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cynosure, Inc. | 5 | 2017-09-26 |
| Dominion Aesthetic Technologies, Inc. | 3 | 2023-02-17 |
| Hebei JT Medical Co., Ltd. | 1 | 2024-05-13 |
| Lightfective , Ltd. | 1 | 2024-04-16 |
| El.En S.P.A. | 1 | 2023-09-26 |
8 more applicants have PKT clearances. See the full list in Caduvo.
Most recent PKT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240658 | Hebei JT Medical Co., Ltd. | 1060nm laser body slimming machine | 2024-05-13 | 66 |
| K233962 | Lightfective , Ltd. | ReBorn (1050nm) | 2024-04-16 | 123 |
| K231971 | El.En S.P.A. | DEKA PHYSIQ 360 | 2023-09-26 | 85 |
| K231131 | Shanghai Bele Medical Technology Co.,Ltd | Diode Laser Body Sculpture Systems | 2023-06-22 | 62 |
| K222226 | Dominion Aesthetic Technologies, Inc. | EON | 2023-02-17 | 207 |
Recalls for PKT devices
openFDA lists no recalls for product code PKT.
Frequently asked questions
What is FDA product code PKT?
PKT is the FDA product code for laser for disruption of adipocyte cells for aesthetic use. It is a Class II device, regulated under 21 CFR 878.5400 and reviewed by the General and Plastic Surgery panel.
What device class is PKT?
Class II, regulation 21 CFR 878.5400. Typical premarket route: 510(k).
How long does a 510(k) take for product code PKT?
Across 19 cleared submissions the average was 144 days from receipt to decision (median 97).
Which companies have the most PKT clearances?
Cynosure, Inc. (5); Dominion Aesthetic Technologies, Inc. (3); Hebei JT Medical Co., Ltd. (1); Lightfective , Ltd. (1); El.En S.P.A. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PKT
- Run a recall and safety report across every PKT manufacturer
- Watch product code PKT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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