Shenzhen Hanhua Opto Co., Ltd. · Class II · Cleared Mar 3, 2026
| K-number | K253874 |
| Device name | LED Therapy Light (COB1400, HP1800PRO) |
| Applicant | Shenzhen Hanhua Opto Co., Ltd. |
| Product code | OHS |
| Device class | Class II |
| Decision date | Mar 3, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The LED Therapy Light (models COB1400, HP1800PRO) is an over-the-counter device that emits red and near-infrared light for treating full-face wrinkles and providing topical heating for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, stiffness, and to increase local blood circulation.
The device uses dual-spectrum LEDs emitting red light (660 nm) and near-infrared light (850 nm) with irradiance ranging from 1.425 to 7.687 mW/cm² depending on mode, with maximum treatment time of 30 minutes per session. The wavelengths and irradiance levels fall within the range of predicate devices.
IEC 60601-1:2005+AMD1:2012+AMD2:2020 (medical electrical equipment safety), IEC 60601-2-57:2023 (non-laser light source equipment), IEC 60601-2-83:2019+AMD1:2022 (home light therapy equipment), IEC 62471:2006 (photobiological safety), and IEC 62304:2006+AMD1:2015 (medical device software life cycle).
The LED Therapy Light is substantially equivalent to three predicate devices (K223544, K212275, K171323) because it has the same intended use for wrinkle treatment and topical heating, uses identical LED light source technology, operates at comparable wavelengths and irradiance levels, and follows similar treatment protocols. Performance data demonstrates safety and effectiveness equivalent to the predicates.
View the full FDA submission: accessdata.fda.gov