Before purchasing any wellness device — especially one that involves light therapy — it's reasonable to ask: where does this company operate, and what has been independently verified about the product?
This page exists to answer that question directly. No marketing language. Just the facts.
Where Mitolux currently ships
Mitolux LLC is headquartered in the United States. Active markets include:
Tier 1 — Primary markets: United States (all states), United Kingdom, Nordic countries (Sweden, Norway, Denmark, Finland).
Tier 2 — Active markets: Germany and DACH region, UAE/Dubai, Australia.
Note on Canada: Following a Health Canada consumer advisory issued in August 2025 regarding the licensing status of UV sunlamp devices, Mitolux paused direct sales to Canadian consumers while the regulatory process for that market is evaluated.
Current certifications
Mitolux holds two active credentials:
FDA Registered (United States): Mitolux is registered with the US Food and Drug Administration as a device establishment. FDA registration is the federal record confirming the facility and its products are listed with the FDA. This is separate from device clearance or approval and is a requirement for wellness device companies operating in the US market.
Lifespan Certified — Entity for Human Longevity: The Mitolux BTS2 is certified by the Entity for Human Longevity under the Lifespan Certified program, which evaluates wellness products against evidence-based standards in longevity and human performance. This is an independent third-party validation recognized in the longevity and biohacking communities.
What FDA Registration means
FDA Registration means that Mitolux LLC is formally listed in the FDA's database as an establishment that manufactures, distributes, or imports devices. It is a required filing for companies in the device space and demonstrates that Mitolux operates within the FDA's regulatory framework.
Mitolux currently positions the BTS2 as a general wellness device in the US — a category that does not require device clearance (510(k)) but does require establishment registration and product listing. This is the standard operating framework for wellness devices that make no diagnostic or therapeutic claims.
For more information on how the FDA categorizes wellness vs. medical devices: FDA Overview of Device Regulation
A note on transparency
This page will be updated as certification statuses change. If you are a prospective buyer in a market not listed above or have a question about a specific certification, you can contact Mitolux directly through the website's contact page.
We believe that buyers making a considered purchase decision deserve accurate, current information — not silence or spin.
Disclaimer: Mitolux is intended for general wellness and self-care use. Individual experiences vary. This content is for informational purposes only and does not constitute medical advice. Mitolux is not intended to diagnose, treat, cure, or prevent any disease. Use only as directed.