Everything people ask us

For the specific indications they are 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 is not is a replacement for in-clinic treatment. Professional devices run at higher power under supervision. A home mask works more gradually, and results vary between people.

Photobiomodulation — the technical name — uses specific wavelengths of visible and near-infrared light to prompt responses in skin cells. Different wavelengths reach different depths and do different work.

This mask emits four: 415 nm blue, 590 nm yellow, 660 nm red and 850 nm near-infrared. It blends them across six programmed modes so you are not guessing which colour to run.

Depth. Red light at 660 nm works in the mid-dermal layer, where collagen and elastin activity happens. Near-infrared at 850 nm penetrates deeper and supports repair of damaged dermal tissue.

Near-infrared is invisible to the human eye. When the mask is running 850 nm on its own it will look as though nothing is happening. Something is.

Different tools. A panel covers more of the body but sits at a distance, so intensity drops across the treatment area and you have to stay still in front of it. A mask sits in contact with the face, delivers consistent coverage across every contour, and leaves you free to move around.

If your goal is facial skin specifically, a mask is the more practical device. If you want to treat larger areas, a panel makes more sense.

We are not going to declare ourselves the best. What we can tell you is what most Canadian sellers cannot: this device holds a Health Canada Medical Device Licence issued to byTheia directly, not to a supplier, and an FDA 510(k) clearance.

Both certificate numbers are published on our certifications page. Ask any brand you are comparing us to for the same two documents, then decide for yourself.

The correct term is cleared, not approved, and the difference is legally meaningful. FDA clears Class II devices like this one through the 510(k) premarket notification process. Approval is a separate, stricter pathway reserved for Class III devices.

This mask is cleared under K250830. Under 21 CFR 807.97, describing a 510(k)-cleared device as "FDA approved" is misbranding — so if you see that phrase on an LED mask listing, the seller either does not understand their paperwork or is hoping you do not.

It holds Medical Device Licence No. 115387, issued under Section 36 of the Medical Devices Regulations as a Class 2 device. That licence is what legally authorises sale of a medical device in Canada — an FDA clearance or a CE mark does not.

Ours is issued to kobeswh.com Inc. DBA byTheia. Many brands sell devices licensed to an overseas manufacturer or importer; that licence does not transfer and is not theirs to cite.

Reproduced from Form FDA 3881:

• Red light — treatment of full-face wrinkles
• Yellow light — treatment of full-face wrinkles
• Red plus infrared light — treatment of full-face wrinkles
• Blue light — treatment of mild to moderate inflammatory acne
• Mixed light — treatment of mild to moderate inflammatory acne

Everything we claim on this website sits inside those indications and the intended-use statement on our Health Canada-licensed labelling.

Please do. The FDA 510(k) database is public — search K250830 at accessdata.fda.gov. Health Canada's Medical Devices Active Licence Listing is public too — search licence number 115387 or company kobeswh.com.

Both full documents are also published on our certifications page.

This one emits no UV and is a licensed Class II medical device with a 510(k) clearance behind it.

Before your first session, run the sensitivity test: place the device on your forearm for ten minutes, then check the skin. Mild redness that fades within one to two hours is normal. If redness, itching or irritation persists, stop and speak to a healthcare professional before using it on your face.

Do not use this device if you are pregnant, planning a pregnancy, or breastfeeding without first consulting a healthcare professional. This is a contraindication on our licensed labelling, not a precaution we have added.

The reason is not that harm has been demonstrated — it is that pregnancy is routinely excluded from device studies, so the evidence base does not exist. We would rather say that plainly than reassure you on the basis of nothing.

Always wear the supplied silicone goggles. They come in the box and are not optional.

The mask has eye openings, and the LEDs surrounding them are bright. Even without UV, direct high-intensity light exposure to the retina over repeated sessions is not something to gamble with. Put the goggles on before you fit the mask, every session.

Do not use it if you:

• Are pregnant, planning pregnancy, or breastfeeding
• Have a photosensitivity disorder, or take medication that causes photosensitivity
• Have lupus erythematosus, photosensitive eczema, or albinism

It is not intended for use by or on infants and children. If you have a skin condition under active treatment, or take any medication you are unsure about, ask your doctor or pharmacist first.

Not on the same day. Retinoids, acid exfoliants and several other actives increase photosensitivity, which raises the risk of irritation.

Alternate them. Light therapy on one evening, actives on another. If you are unsure whether something in your routine is photosensitising, check with a pharmacist.

It warms gently during a session, which is normal for a device drawing up to 15 W. It should never be uncomfortable. If it feels hot rather than warm, power it off and contact us at cs@bytheiallc.com.

Cleanse your face and make sure skin is dry and free of makeup. Put on the silicone goggles. Place the mask over your face and secure the adjustable strap. Hold the power button for three seconds, select your mode, and adjust brightness to comfort.

It stops automatically at the end of the preset session. Remove it by the strap and power off.

Three to four times per week, 10 to 20 minutes per session, unless a healthcare professional advises otherwise.

More is not better. Consistency over weeks is what produces change, and daily use does not accelerate it.

• Wrinkles and firmness — Mode 3 (Anti-aging, 660 + 850 nm)
• Acne — Mode 5 (415 nm), or Mode 6 to combine with repair wavelengths
• Tone and pigmentation — Mode 2 (590 + 660 nm)
• Redness and recovery — Mode 1 (660 nm)
• Texture and puffiness — Mode 4 (590 + 660 + 850 nm)

Pick one goal and stay with it for six weeks rather than rotating every session.

On clean, dry skin, before serums and moisturiser. Light penetrates bare skin better than skin under a layer of product, and some ingredients are photosensitising.

Apply your serums and moisturiser after the session.

Wipe the inner surface with a soft, dry cloth after each session. Never immerse it in water or rinse it under a tap. Store it cool, dry, and out of direct sunlight.

5000 mAh, charged over USB-C at 5 V / 2 A in roughly three hours. Charge it fully before first use. It is cordless in the sense that it runs on battery — you do not need to sit beside a wall socket.

Yes. It is foldable medical-grade silicone with an adjustable buckle and runs on battery, so it is designed to be worn hands-free while you move around the house rather than lying still.

Many people notice increased radiance and smoother texture within a few weeks. Changes in firmness, fine lines and pigmentation take longer and differ considerably from person to person.

We know competitors promise four weeks. We would rather tell you what our own licensed labelling says. Individual results vary.

Because we are a new brand and do have limited ones, We are trying get one from customers who genuinely get results

We are in process of having photographs from real customers, taken under consistent conditions and used with written permission, we will publish them.

Light therapy is maintenance, not a one-time correction. Skin cell turnover continues, and so does ageing. Most people settle into an ongoing routine of a few sessions a week rather than a fixed course with an end date.

We cannot say it will, because neither our FDA clearance nor our Health Canada licence covers those conditions. You will find LED masks marketed for all of them. Not this one.

If you have a diagnosed skin condition, speak to a dermatologist about whether light therapy has a role in your treatment.

Markham, Ontario. Orders typically leave within one business day and arrive in two to five business days. Shipping is free across Canada, with no customs charges and no month-long wait from an overseas warehouse.

Return it within 30 days of delivery for a full refund, even if you have used it. An opened box does not void your refund. Return shipping is free across Canada and there is no restocking fee.

Email cs@bytheiallc.com with your order number and we will send a prepaid label. Full terms are in our refund policy.

Twelve months from purchase, provided the device has been used according to the manual. If it develops a fault we will repair or replace it at no charge.

The warranty does not cover misuse, disassembly, water exposure, or cosmetic wear. Do not attempt to open or repair the device — it contains a lithium battery and disassembly is both a warranty and a safety issue.

Face mask, controller with OLED screen, USB-C charging cable, silicone safety goggles, adjustable buckle, travel case, and a bilingual user manual in English and French.

No. This is a face-only device. A face-and-neck variant is not currently licensed by Health Canada and we do not sell it.

We used to sell five. Only one of them could carry a Health Canada licence, and selling four that could not — alongside one that could — made the certification story meaningless.

One device, fully documented, is a better offer than five with an asterisk.