PKT · Laser For Disruption Of Adipocyte Cells For Aesthetic Use
General, Plastic Surgery · 21 CFR 878.5400 · Class 2
Overview
| Product Code | PKT |
|---|---|
| Device Name | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Regulation | 21 CFR 878.5400 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| GMP Exempt | Yes |
Identification
A Low Level Laser System for Aesthetic Use is a device using low level laser energy for the disruption of adipocyte cells within the fat layer for the release of fat and lipids from these cells for noninvasive aesthetic use.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | May 13, 2024 | SESE |
| K233962 | ReBorn (1050nm) | Lightfective , Ltd. | Apr 16, 2024 | SESE |
| K231971 | DEKA PHYSIQ 360 | El.En S.P.A. | Sep 26, 2023 | SESE |
| K231131 | Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd | Jun 22, 2023 | SESE |
| K222226 | EON | Dominion Aesthetic Technologies, Inc. | Feb 17, 2023 | SESE |
| K222265 | Diosculpt | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | Sep 23, 2022 | SESE |
| K211681 | EON | Dominion Aesthetic Technologies, Inc. | Mar 30, 2022 | SESE |
| K212331 | BodySculp | Rohrer Aesthetics, LLC | Nov 9, 2021 | SESE |
| K211402 | Powersculp laser lipolysis system | Lotuxs Medtech (Suzhou) Co., Ltd. | Jul 30, 2021 | SESE |
| K192970 | SLIMUS | Hironic Co., Ltd. | Dec 1, 2020 | SESE |
| K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | Sep 10, 2020 | SESE |
| K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | Jul 17, 2019 | SESE |
| K180511 | Eon FR | Dominion Aesthetic Technologies, Inc. | Jun 12, 2019 | SESE |
| K182741 | SculpSure | Cynosure | Jan 3, 2019 | SESE |
| K171992 | SculpSure | Cynosure, Inc. | Sep 26, 2017 | SESE |
| K171111 | Sculpsure | Cynosure, Inc. | Jun 13, 2017 | SESE |
| K160470 | SculpSure | Cynosure, Inc. | Jul 21, 2016 | SESE |
| K150724 | SculpSure | Cynosure, Inc. | Jul 1, 2015 | SESE |
| K150230 | SculpSure | Cynosure, Inc. | May 15, 2015 | SESE |
Top Applicants
- Cynosure, Inc. — 5 clearances
- Dominion Aesthetic Technologies, Inc. — 3 clearances
- Cynosure — 1 clearance
- El.En S.P.A. — 1 clearance
- Hebei JT Medical Co., Ltd. — 1 clearance
