Shenzhen Kaiyan Medical Equipment Co., Ltd. · Class II · Cleared Apr 15, 2026
| K-number | K260129 |
| Device name | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) |
| Applicant | Shenzhen Kaiyan Medical Equipment Co., Ltd. |
| Product code | OLI |
| Device class | Class II |
| Decision date | Apr 15, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.5400 |
The Lumaflex Panel (models ZLD-05, ZLD-05A, ZLD-05APro) is an over-the-counter LED light therapy device for aesthetic and therapeutic use. It emits red and near-infrared light wavelengths (630–1064 nm depending on model) to reduce circumference of hips/waist/thighs, treat facial wrinkles, and provide temporary relief of minor muscle and joint pain.
The device uses light-emitting diodes (LEDs) in multiple treatment modes with varying wavelengths and intensities. ZLD-05 and ZLD-05A emit 630 nm and 850 nm; ZLD-05APro adds 660 nm, 810 nm, 904 nm, and 1064 nm. The device is powered by a rechargeable battery controller; ZLD-05 and ZLD-05APro offer app-based Bluetooth control, while ZLD-05A uses a single physical button. Treatment times range from 10–30 minutes depending on mode.
IEC 60601-1 (electrical safety), IEC 60601-1-11 (home healthcare), IEC 60601-2-57 (non-laser light source equipment), IEC 60601-1-2 (electromagnetic compatibility), and IEC 62471 (photobiological safety of lamps). Software verification and validation followed FDA guidance for medical device software; cybersecurity documentation was created per FDA April 2026 guidance.
View the full FDA submission: accessdata.fda.gov