Guangdong Newdermo Biotech Co., Ltd. · Class II · Cleared Mar 23, 2026
| K-number | K260202 |
| Device name | LED Light Therapy Masks (LumiLips FAC07NA) |
| Applicant | Guangdong Newdermo Biotech Co., Ltd. |
| Product code | OHS |
| Device class | Class II |
| Decision date | Mar 23, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
The LED Light Therapy Mask (LumiLips FAC07NA) is an over-the-counter home-use device that emits four wavelengths of light (red 630nm, amber 605nm, dark red 660nm, and near-infrared 880nm) to treat fine lines and wrinkles and increase circulation in the perioral (lip) region. It consists of an LED lip mask, removable mouthpiece, and charging cable powered by a rechargeable lithium-ion battery or USB adapter.
The subject device operates at 40 mW/cm² power density for 5 minutes per treatment session, delivering approximately 12 J/cm² total dose. This is lower power density than predicate devices (67.7 mW/cm²) but achieves the same cumulative dose over a longer treatment time. It uses LED light sources at the same four wavelengths as predicates and includes the same safety and electromagnetic compliance standards with additional biocompatibility testing.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471, IEC 62133-2, ISO 10993-5, ISO 10993-10, ISO 10993-23 for biocompatibility and safety. Software verification and validation documented per FDA guidance.
View the full FDA submission: accessdata.fda.gov