Our certifications, published in full

What these two documents mean

There is no single global authorisation for a medical device. Each country decides for itself. That is why a mask 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

This is the authorisation that governs whether this device 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 document above is an MDL.

FDA 510(k) K250830

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.

"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.

Cleared indications for use

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

Everything we claim on this website sits inside those indications and the intended-use statement 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

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.

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 company kobeswh.com.

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