Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart F — Therapeutic Devices](/submissions/SU/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 878.5400](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5400) → PKT — Laser For Disruption Of Adipocyte Cells For Aesthetic Use # PKT · Laser For Disruption Of Adipocyte Cells For Aesthetic Use _General, Plastic Surgery · 21 CFR 878.5400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT ## Overview - **Product Code:** PKT - **Device Name:** Laser For Disruption Of Adipocyte Cells For Aesthetic Use - **Regulation:** [21 CFR 878.5400](/submissions/SU/subpart-f%E2%80%94therapeutic-devices/878.5400) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K240658.md) | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | May 13, 2024 | SESE | | [K233962](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K233962.md) | ReBorn (1050nm) | Lightfective , Ltd. | Apr 16, 2024 | SESE | | [K231971](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K231971.md) | DEKA PHYSIQ 360 | El.En S.P.A. | Sep 26, 2023 | SESE | | [K231131](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K231131.md) | Diode Laser Body Sculpture Systems | Shanghai Bele Medical Technology Co.,Ltd | Jun 22, 2023 | SESE | | [K222226](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K222226.md) | EON | Dominion Aesthetic Technologies, Inc. | Feb 17, 2023 | SESE | | [K222265](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K222265.md) | Diosculpt | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | Sep 23, 2022 | SESE | | [K211681](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K211681.md) | EON | Dominion Aesthetic Technologies, Inc. | Mar 30, 2022 | SESE | | [K212331](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K212331.md) | BodySculp | Rohrer Aesthetics, LLC | Nov 9, 2021 | SESE | | [K211402](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K211402.md) | Powersculp laser lipolysis system | Lotuxs Medtech (Suzhou) Co., Ltd. | Jul 30, 2021 | SESE | | [K192970](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K192970.md) | SLIMUS | Hironic Co., Ltd. | Dec 1, 2020 | SESE | | [K201731](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K201731.md) | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | Sep 10, 2020 | SESE | | [K191068](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K191068.md) | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | Jul 17, 2019 | SESE | | [K180511](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K180511.md) | Eon FR | Dominion Aesthetic Technologies, Inc. | Jun 12, 2019 | SESE | | [K182741](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K182741.md) | SculpSure | Cynosure | Jan 3, 2019 | SESE | | [K171992](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K171992.md) | SculpSure | Cynosure, Inc. | Sep 26, 2017 | SESE | | [K171111](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K171111.md) | Sculpsure | Cynosure, Inc. | Jun 13, 2017 | SESE | | [K160470](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K160470.md) | SculpSure | Cynosure, Inc. | Jul 21, 2016 | SESE | | [K150724](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K150724.md) | SculpSure | Cynosure, Inc. | Jul 1, 2015 | SESE | | [K150230](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT/K150230.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/PKT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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