Where to buy
What it’s cleared for
The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
From the FDA filing (K241933, page 4) — verbatim · retrieved 2026-10-22
Key specs
- Light wavelengths
- Red 630 nm and near-infrared 830 nm Source · retrieved 2026-10-22
- LED count
- 66 dual-core LEDs (132 diodes) Source · retrieved 2026-10-22
- Suggested use
- 10 minutes 4-5 times a week or 20 minutes 3-4 times a week Source · retrieved 2026-10-22
- Treatment areas
- face Source · retrieved 2026-10-22
The FDA record
FDA record K241933 lists the device as “HIGHERDOSE Red and Infrared Light Mask (MK66-L)”. The evidence below shows how we matched this exact model.
“Cleared” means the FDA found the device substantially equivalent to one already legally sold, for a stated use. It isn’t proof it works for you. FDA: premarket notification 510(k)
K241933 · View FDA record
- Device name in the FDA record
- HIGHERDOSE Red and Infrared Light Mask (MK66-L)
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decision date
- 2024-09-27
- Product code
- OHS: Light Based Over The Counter Wrinkle Reduction
- Evidence
- FDA GUDID brand HIGHERDOSE model MK66-L cites K241933; FDA summary: red 630nm + NIR 830nm; manufacturer page https://higherdose.com/products/red-light-face-mask states 'FDA-cleared', 630nm red and 830nm near-infrared, 66 dual-core LEDs (132 diodes). Source; retrieved 2026-10-22.
Safety notes
Before you use it
- Skip it if you have a light-sensitive condition such as lupus. Source: American Academy of Dermatology: is red light therapy right for your skin?
Precautions
- Wear eye protection if the directions tell you to, using the eye protection that's recommended. Source: American Academy of Dermatology: is red light therapy right for your skin?