byTheia Advanced LED Light Therapy Facial Mask in 660nm red light mode, a Health Canada licensed Class II medical device

The LED face mask Canada actually licensed

Class II medical device, licensed by Health Canada in byTheia's own name, cleared by the FDA, and shipped from Markham, Ontario.

Introductory Price - Just 199.99$
Woman receiving a ten-minute 660nm red light therapy session with the byTheia LED face mask

Treatment-grade. No appointment.

Ten minutes, three times a week, on your own sofa. Licensed by Health Canada as a Class II medical device.

View Certifications
K250830 FDA 510(k) Cleared
K250830 FDA 510(k) Cleared
MDL 115387 Health Canada Licensed
MDL 115387 Health Canada Licensed
Class II Medical Device
Class II Medical Device
Medical Grade Silicone, foldable
Medical Grade Silicone, foldable
12 Months Warranty
12 Months Warranty
Free Shipping All Over Canada
Free Shipping All Over Canada
K250830 FDA 510(k) Cleared
K250830 FDA 510(k) Cleared
MDL 115387 Health Canada Licensed
MDL 115387 Health Canada Licensed
Class II Medical Device
Class II Medical Device
Medical Grade Silicone, foldable
Medical Grade Silicone, foldable
12 Months Warranty
12 Months Warranty
Free Shipping All Over Canada
Free Shipping All Over Canada
  • byTheia's FDA 510(k) clearance and Health Canada Medical Device Licence, both published in full

    Two certificates. Both published. One Mask

    Shopping for an LED mask in Canada mostly means trusting a product photo. Brands write "FDA approved", a phrase that doesn't exist for this category. They write "Health Canada certified" without saying what was certified, by whom, or under which number. We'd rather just show you.

    View Certifications 
  • byTheia LED mask showing its four wavelengths — 415nm blue, 590nm yellow, 660nm red and 850nm near-infrared

    Four wavelengths. Six modes. One mask

    Ten minutes, three to five times a week, six weeks to visible change. No subscriptions. No serums you have to keep buying. Just the device, the routine, and your skin doing what skin does when you give it the right light.

    See full Specifications 

Advanced LED Light Therapy Facial Mask

A Class II medical device for wrinkles and breakouts. Four wavelengths - 415, 590, 660 and 850 nm - across six programmed therapy modes. Medical-grade silicone, ten-minute sessions, three to four times a week.

$199.99
Cleared for treatment of full-face wrinkles and mild to moderate inflammatory acne

Key Features

  • Health Canada Medical Device Licence No. 115387
  • FDA 510(k) cleared — K250830
  • Four wavelengths: 415, 590, 660 and 850 nm
  • Six programmed therapy modes, three energy levels
  • Medical-grade silicone · 12-month warranty
Free shipping
30-day returns
Secure checkout
Photobiomodulation

What LED light therapy actually does

Different wavelengths reach different depths and do different work. That's the whole idea — and it's why the wavelengths a mask emits matter more than how many lights sit on the front of it.
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660 NM · RED · Fine lines and Wrinkles

Red light supports collagen and elastin activity, reducing the appearance of fine lines and improving firmness and elasticity. This is the indication both regulators reviewed.
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415 NM · BLUE · Breakouts

Blue light targets acne-causing bacteria. Cleared by the FDA specifically for mild to moderate inflammatory acne — not as a vague promise of clear skin.
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590 NM · YELLOW · Uneven Tone

Yellow light supports skin renewal and local microcirculation, helping a dull or uneven complexion look more even.

850 NM · NEAR-IR · Redness and Recovery

Near-infrared reaches deepest, supporting repair of damaged dermal tissue and helping reduce inflammation and redness. You won't see it working.

Before & After

Six-week treatment cycle, three 10-minute sessions per week. Results vary; individual experience may differ.

Before
After
Before
After
Before
After
Before
After

Frequently Asked Questions

Find answers to common questions about our products

For the specific indications they're cleared for, yes. This device is cleared by the FDA for treatment of full-face wrinkles using red, yellow, or red-plus-infrared light, and for mild to moderate inflammatory acne using blue or mixed light. That clearance follows a substantial-equivalence review of the underlying evidence. What it isn't is a replacement for in-clinic treatment and results vary between people.

The correct term is cleared, not approved. FDA clears Class II devices like this one through the 510(k) premarket notification process; approval is a separate, stricter pathway used for Class III devices. This mask is cleared under K250830. For sale in Canada, the authorisation that actually matters is the Health Canada Medical Device Licence — ours is No. 115387.

Yes. Everything ships from Markham, Ontario, typically within 1-3 business day.

We're not going to declare ourselves the best. What we can tell you is what most Canadian sellers can't: this device holds a Health Canada Medical Device Licence issued to byTheia directly, and an FDA 510(k) clearance. Both numbers are published on our certifications page. Ask any brand you're comparing us to for the same two documents, then decide for yourself.

This one emits no UV and is a licensed Class II medical device. Before first use, run the light-sensitivity test on your forearm: ten minutes of exposure, then check the skin. Mild redness that fades within one to two hours is normal.

Don't use it if you're pregnant, planning pregnancy, or breastfeeding; if you have a photosensitivity disorder or take photosensitising medication; or if you have lupus erythematosus, photosensitive eczema, or albinism. Always wear the goggles.

Cross-section illustration of LED light penetrating skin layers

How light changes your skin

Red and near-infrared light reach the mitochondria inside your skin cells - the part of the cell that produces ATP, the energy currency that powers everything from collagen synthesis to wound healing. Blue light, at 415nm, targets the bacteria that drive most breakouts. Different wavelengths do different work. The right mask gives you the ones that matter most for your skin, in the right combination, at the right intensity.