FDA product code OLI: Fat Reducing Low Level Laser
OLI is the FDA product code for fat reducing low level laser. It is a Class II device, regulated under 21 CFR 878.5400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 32 510(k) submissions under OLI, 10 in the last five years, from 14 different applicants. The average 510(k) review took 136 days (median 104); 136 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for OLI devices.
Definition
Non-invasive reduction in fat layer for body contouring
Classification
| Field | Value |
|---|---|
| Device name | Fat Reducing Low Level Laser |
| 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) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for OLI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 111 |
| 2018 | 1 | 226 |
| 2020 | 3 | 201 |
| 2021 | 1 | 231 |
| 2022 | 2 | 78 |
| 2023 | 2 | 60 |
| 2025 | 3 | 81 |
| 2026 | 3 | 192 |
Compare with all 510(k) review times · Search every OLI clearance
Top OLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Erchonia Corporation | 13 | 2025-12-15 |
| Ward Photonics, LLC | 3 | 2020-12-18 |
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2 | 2026-05-04 |
| Contour Research, LLC | 2 | 2026-02-13 |
| Yolo Medical, Inc. | 2 | 2017-06-06 |
9 more applicants have OLI clearances. See the full list in Caduvo.
Most recent OLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260688 | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | 2026-05-04 | 62 |
| K260129 | Shenzhen Kaiyan Medical Equipment Co., Ltd. | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | 2026-04-15 | 89 |
| K243854 | Contour Research, LLC | Contour Light (CL-100) | 2026-02-13 | 424 |
| K252574 | Erchonia Corporation | Erchonia CLX (Model # CFL) | 2025-12-15 | 123 |
| K252786 | Shenzhen Suyzeko Limited. | Led Light Phototherapy Bed (Pro 450/ GY-680A) | 2025-12-01 | 90 |
Recalls for OLI devices
3 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-05-06.
Frequently asked questions
What is FDA product code OLI?
OLI is the FDA product code for fat reducing low level laser. 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 OLI?
Class II, regulation 21 CFR 878.5400. Typical premarket route: 510(k).
How long does a 510(k) take for product code OLI?
Across 32 cleared submissions the average was 136 days from receipt to decision (median 104).
Which companies have the most OLI clearances?
Erchonia Corporation (13); Ward Photonics, LLC (3); Shenzhen Kaiyan Medical Equipment Co., Ltd. (2); Contour Research, LLC (2); Yolo Medical, Inc. (2).
Have OLI devices been recalled?
Yes: 3 product recalls across 1 recall events; the most recent began 2014-05-06.
Next steps
- Run an FDA pathway report with predicate devices for product code OLI
- Run a recall and safety report across every OLI manufacturer
- Watch product code OLI 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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