Silicone mask at 630, 830 and 465 nm, cleared under its maker’s 510(k), K250581, and measured at 26 mW/cm2.
$340
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Usability
Usability
The face mask is a silicone mask with 66 triple-chip LEDs at 630, 830 and 465 nm on a corded battery controller, run in 10- or 20-minute sessions. Light Therapy Insiders (Alex Fergus), a market-wide tester who was sent the mask free and links to Kala, measured 26 mW/cm2 directly over the red and near-infrared LEDs with a spectrometer in July 2025, against Kala's 20 for red, so light output scores 6. FDA cleared it in May 2025 as the KALA Red Light Face Mask under K250581, a 510(k) held by its maker, Shenzhen Kaiyan Medical Equipment, whose summary matches its wavelengths, output and sessions, so it scores 7 on verification. Testers and owners fault gaps at the jaw, chin and under the eyes. Health Canada lists a recall of one lot in 2025 over an unclear manual. It is $339.99 on kalaredlight.com, sold as final sale.
- 510(k) K250581, held by its maker Shenzhen Kaiyan
- 26 mW/cm2 measured over the LEDs by a market-wide tester
- Red, near-infrared and blue in one mask
- Flexible silicone with a 10- or 20-minute timer
- 2-year warranty
- Gaps under the eyes, at the jaw and at the chin, per a tester and an owner
- Controller corded to the mask
- One lot recalled in Canada in 2025 over an unclear manual
- Final sale, with no return
- Amazon file split: 70 percent five-star, 19 percent one-star
The face mask is a flexible silicone mask, 11.73 by 8.50 by 0.20 inches and 12.3 oz, carrying 66 triple-chip LEDs at 630 nm red, 830 nm near-infrared and 465 nm blue, 198 light sources in all. A battery controller corded to the mask runs 10- or 20-minute sessions. Kala states 20 mW/cm2 red, 10 near-infrared and 10 blue. Kala's warranty covers it for 2 years, and Kala sells it as final sale.
Additional information
Specification: Kala Red Light Face Mask
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