Our certifications, published in full

What these documents mean

There is no single global authorisation for a medical device. Each country decides for itself. That is why a device can be legally sold in one market and not another — and why "certified" on its own tells you nothing.

Health Canada Medical Device Licence No. 115387 — the mask

This is the authorisation that governs whether the mask may legally be sold in Canada. It was issued under Section 36 of the Medical Devices Regulations to kobeswh.com Inc., DBA byTheia — our own legal entity, not a supplier's — for the Advanced LED Light Therapy Facial Mask, device identifier BTFM03, as a Class 2 medical device.

Two details worth understanding. It is issued in our name. Many brands sell devices licensed to an overseas manufacturer or an importer; that licence does not transfer, and it is not theirs to cite. Ours names byTheia directly.

A Medical Device Licence is not an Establishment Licence. An MDEL authorises a company to import or distribute. An MDL authorises a specific device. The two are frequently confused in marketing copy. The documents above are MDLs.

Health Canada Medical Device Licence No. 115591 — the thermometer

The same standard, applied a second time. Licence 115591 was issued on 15 June 2026, again under Section 36 and again to kobeswh.com Inc., DBA byTheia, for the Dual Mode Infrared Thermometer, device identifier BTTM01, as a Class 2 medical device.

Clinical electronic thermometers are Class 2 in Canada, the same class as the mask. A licence is required before sale, and it is device-specific: this one covers the BTTM01 and nothing else. Plenty of thermometers reach Canadian customers through marketplace listings without one.

FDA 510(k) K250830 — the mask

The U.S. Food and Drug Administration cleared this device platform on 9 June 2025 under 21 CFR 878.4810, as a Class II device, product codes OHS and OLP. The 510(k) is held by the manufacturer of the LED module and covers the device family this mask belongs to — which is why we say the mask is cleared under K250830 rather than calling it our clearance. The authorisation held in byTheia's own name is the Health Canada licence above.

"Cleared" is not "approved." These are different regulatory pathways and the distinction is legally meaningful. Class II devices go through 510(k) premarket notification, where the FDA determines the device is substantially equivalent to an existing legally marketed one. Approval is a separate, stricter pathway reserved for Class III devices. Under 21 CFR 807.97, describing a 510(k)-cleared device as "FDA approved" is misbranding.

If you see "FDA approved" on an LED mask listing, the seller either does not understand their own paperwork or is hoping you do not.

Why the thermometer has no FDA number

Because there is nothing to show. Clinical electronic thermometers of this type fall under 21 CFR 880.2910, product code SDV, and the FDA has exempted the entire category from 510(k) premarket notification. No submission is filed, no review takes place, and no clearance is issued — to us or to anyone else selling an ear and forehead thermometer.

We could dress that up as "FDA exempt" and put it in a badge. We would rather tell you it means nothing. For a thermometer sold in Canada, the authorisation that actually counts is the Health Canada licence above.

Cleared indications for use — the mask

This is the section that matters most, reproduced from Form FDA 3881:

Intended use — the thermometer

From the licensed labelling: the Dual Mode Infrared Thermometer is intended for the measurement of human body temperature in the home setting and in medical institutes.

That is the whole of it. A thermometer measures temperature. It does not diagnose anything, and a reading is not a substitute for medical advice.

Everything we claim on this website sits inside those indications and the intended-use statements on our Health Canada-licensed labelling. If we ever say something that does not, we have made a mistake — tell us at cs@bytheiallc.com and we will correct it.

What these documents do not say

For the mask, neither authorisation covers rosacea, eczema, psoriasis, melasma, sun-damage reversal, scar removal, hair growth, pain relief, or any comparison to in-clinic laser or IPL outcomes. You will find LED masks marketed for all of those. Not this one.

For the thermometer, the licence covers measurement of body temperature. It says nothing about detecting illness, screening for infection, or clearing anyone to be around other people.

How to verify these yourself

The FDA 510(k) database is public — search K250830 at accessdata.fda.gov. The Health Canada Medical Devices Active Licence Listing is public too — search licence number 115387 or 115591, or company kobeswh.com.

Do not take our word for any of this. That is rather the point of publishing it.