Shenzhen Suyzeko Limited. · Class II · Cleared Dec 1, 2025
| K-number | K252786 |
| Device name | Led Light Phototherapy Bed (Pro 450/ GY-680A) |
| Applicant | Shenzhen Suyzeko Limited. |
| Product code | OLI |
| Device class | Class II |
| Decision date | Dec 1, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.5400 |
The Led Light Phototherapy Bed (Pro 450/GY-680A) is a non-invasive aesthetic treatment device using red and infrared LED light (630nm, 660nm, 855nm, 940nm wavelengths) to reduce circumference of hips, waist, and thighs, and to provide topical heating for temporary relief of minor muscle and joint pain, muscle spasm, and arthritis-related stiffness while promoting muscle relaxation and increasing local blood circulation.
The device's slimming mode uses 630nm wavelength at 4.1 mW/cm² irradiance with 30-minute treatment time, similar to predicate K202955 (635nm at 4.1 mW/cm²). The pain relief mode uses 630nm, 660nm, 855nm, and 940nm wavelengths at 58-60 mW/cm² irradiance, matching predicate K153399 (60 mW/cm²). The device structure is identical to predicate K153399, consisting of two adjustable LED panels with software control console, power adapter, and safety features including an emergency stop button.
IEC 60601-1:2005 (medical electrical equipment general safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-2-57:2011 (collateral EMC standard), IEC 62471:2006 (photobiological safety of lamps and lamp systems), and enhanced-level software verification and validation documentation per industry standards.
View the full FDA submission: accessdata.fda.gov