Data / Medical devices / Fat Reducing Low Level Laser
Fat Reducing Low Level Laser (OLI): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Fat Reducing Low Level Laser (product code OLI, Class 2, 21 CFR 878.5400). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 33 510(k) clearances under this code, the latest on May 4, 2026, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- OLI
- Device class
- 2
- Regulation
- 878.5400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| China | 4 |
| United Kingdom | 1 |
| Germany | 1 |
Makers of Fat Reducing Low Level Laser
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Erchonia Corporation | Fountain Inn, SC, United States | Complaint file establishment, Manufacturer, Remanufacturer | 8 | December 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Photonica USA LLC | Cocoa Beach, FL, United States | Complaint file establishment, Manufacturer | 3 | December 18, 2020 | 0 | 1 | 0 | api.fda.gov |
| Shenzhen Kaiyan Medical Equipment Co., Ltd | Shenzhen Guangdong, China | Exporter to the US, Manufacturer | 2 | May 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Biophotas, Inc. | Tustin, CA, United States | Complaint file establishment, Manufacturer | 1 | November 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Contour Research LLC | Reno, NV, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | May 19, 2021 | 0 | 0 | 0 | api.fda.gov |
| IR Technology, LLC | Woodstock, GA, United States | Specification developer | 1 | August 19, 2020 | 0 | 0 | 0 | api.fda.gov |
| Laser Lipo Limited | Edenbridge Kent, United Kingdom | Manufacturer | 1 | September 6, 2013 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Suyzeko Limited | Shenzhen Guangdong, China | Manufacturer | 1 | December 1, 2025 | 0 | 0 | 0 | api.fda.gov |
| Beijing Syntech Laser Co., Ltd. | Beijing, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| KBL GmbH | Dernbach Rhineland-Palatinate, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Rohrer Aesthetics, Inc. | Homewood, AL, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhengzhou PZ Laser Slim Technology Co., Ltd | Zhengzhou City Henan, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.