510(k) submissions
Filtered by LED · showing 1–17 of 17
| K number | Device name | Company | Technology | Class | Decision |
|---|---|---|---|---|---|
| K251727 | GLAM LED Facial Mask (TB-2386F)Acne treatment | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-08-29 |
| K243993 | Photon Therapy Apparatus (BL-10)Pigment treatment | Xemis Medical Technology (Shenzhen) Co., Ltd.China | LED | Class 2 | 2025-03-13 |
| K241293 | LED Light Therapy Device, ELIXIR MD™Acne treatment | Yassen Wellness, LLCUnited States | LED | Class 2 | 2024-07-08 |
| K241358 | BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170EAcne treatment | Sun Pharmaceutical Industries, Inc.United States | LED | Class 2 | 2024-06-13 |
| K240222 | Dermalux Tri-Wave MD MKII (1000021); Dermalux Compact MD (1000024)Acne treatment | Aesthetic Technology, Ltd.United Kingdom | LED | Class 2 | 2024-06-04 |
| K240132 | EmoLED (v. 2-USA)Acne treatment | Emoled, SrlItaly | LED | Class 2 | 2024-03-12 |
| K233077 | FlashHeal 2 (FlashHeal 2.0)Acne treatment | Inwound ApsDenmark | LED | Class 2 | 2024-01-18 |
| K231894 | LED Spectrum therapy instrumentAcne treatment | Shenzhenshi Sincoheren S&T Development Co., Ltd.China | LED | Class 2 | 2023-09-20 |
| K230342 | Phototherapy System (OL-PDT950)Acne treatment | Shanghai Omni Laser Skinology Co., Ltd.China | LED | Class 2 | 2023-08-16 |
| K222751 | LED Light Therapy Device, KN-7000LAcne treatment | Xuzhou Kernel Medical Equipment Co., Ltd.China | LED | Class 2 | 2023-02-01 |
| K202175 | OxyLight 2.0Acne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2021-12-02 |
| K210535 | UltraLight LED SystemBody contouring | Rohrer AestheticsUnited States | LED | Class 2 | 2021-05-24 |
| K200104 | OxylightAcne treatment | Raja Trading Company, Inc.United States | LED | Class 2 | 2020-06-04 |
| K200751 | Photodynamic Therapy (PDT) EquipmentAcne treatment | Shangdong Huamei Technology Co., Ltd.China | LED | Class 2 | 2020-05-21 |
| K200659 | Dermalux Tri-Wave MDAcne treatment | Aesthetic Technology, Ltd.United Kingdom | LED | Class 2 | 2020-05-09 |
| K192755 | Soli-Lite LG4 GalileoAcne treatment | Silhouet-Tone CorporationCanada | LED | Class 2 | 2019-12-20 |
| K190938 | Phototherapy SystemAcne treatment | Shanghai Apolo Medical Technology Co., Ltd.China | LED | Class 2 | 2019-06-26 |