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) → OLI — Fat Reducing Low Level Laser # OLI · Fat Reducing Low Level Laser _General, Plastic Surgery · 21 CFR 878.5400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI ## Overview - **Product Code:** OLI - **Device Name:** Fat Reducing Low Level Laser - **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) - **3rd-party reviewable:** 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 (20 of 32) Showing 20 most recent of 32 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K260129](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K260129.md) | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Apr 15, 2026 | SESE | | [K243854](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K243854.md) | Contour Light (CL-100) | Contour Research, LLC | Feb 13, 2026 | SESE | | [K252574](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K252574.md) | Erchonia CLX (Model # CFL) | Erchonia Corporation | Dec 15, 2025 | SESE | | [K252786](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K252786.md) | Led Light Phototherapy Bed (Pro 450/ GY-680A) | Shenzhen Suyzeko Limited. | Dec 1, 2025 | SESE | | [K243811](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K243811.md) | Erchonia Zerona® VZ8 | Erchonia Corporation | Jan 10, 2025 | SESE | | [K232977](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K232977.md) | Biophotas Celluma CONTOUR | Biophotas, Inc. | Nov 21, 2023 | SESE | | [K231474](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K231474.md) | Erchonia Violet ZERONA® Z6 OTC | Erchonia Corporation | Jul 21, 2023 | SESE | | [K220519](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K220519.md) | Erchonia Zerona Z-Bed | Erchonia Corporation | Mar 24, 2022 | SESE | | [K213534](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K213534.md) | PHantom Trilogy | Resurgeonz, LLC | Mar 11, 2022 | SESE | | [K202955](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K202955.md) | Contour Light CL-100 | Contour Research, LLC | May 19, 2021 | SESE | | [K202361](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K202361.md) | UltraSlim Digital, UltraSmooth Digital | Ward Photonics, LLC | Dec 18, 2020 | SESE | | [K192275](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K192275.md) | invisa-RED ELITE | IR Technology, LLC | Aug 19, 2020 | SESE | | [K192544](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K192544.md) | Erchonia Emerald | Erchonia Corporation | Jan 13, 2020 | SESE | | [K180338](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K180338.md) | Cellulize | Ward Photonics, LLC | Sep 21, 2018 | SESE | | [K172111](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K172111.md) | Vevazz LED | Vevazz, LLC | Nov 22, 2017 | SESE | | [K170709](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K170709.md) | CURVE Laser System | Yolo Medical, Inc. | Jun 6, 2017 | SESE | | [K162578](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K162578.md) | Zerona Z6 OTC | Erchonia Corporation | Dec 16, 2016 | SESE | | [K160880](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K160880.md) | Photonica Professional | Ward Photonics, LLC | Sep 23, 2016 | SESE | | [K150446](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K150446.md) | Erchonia Zerona 6 headed scanner EZ6 | Erchonia Corporation | May 21, 2015 | SESE | | [K143741](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI/K143741.md) | Lipofina Laser System | Yolo Medical, Inc. | Apr 24, 2015 | SESE | ## Top Applicants - Erchonia Corporation — 13 clearances - Ward Photonics, LLC — 3 clearances - Contour Research, LLC — 2 clearances - Erchonia Medical, Inc. — 2 clearances - Yolo Medical, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI](https://fda.innolitics.com/submissions/SU/subpart-f%E2%80%94therapeutic-devices/OLI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com