Is ozone therapy approved or regulated by health authorities?

This is the single most market-dependent question in this category, and it is one where a wrong answer creates legal exposure for a buyer.

Our position on the equipment

We sell our ozone saunas as wellness equipment, not medical devices. That is a statement about the equipment we make, and it does not decide how ozone therapy itself is treated where you live.

The oxygen concentrator supplied with the sauna is a medical device in its own right. The model we currently supply is FDA-cleared and CE marked. The FDA clearance applies to the concentrator, not to the sauna.

Ozone therapy is a separate question

In practice:

• The regulatory status of ozone therapy as a treatment and the classification of a device that produces ozone are two different questions. A cabinet can be legally sellable as wellness equipment in a market where ozone therapy is not an approved medical treatment.
• Requirements vary by jurisdiction. South Africa, the United States, the European Union and Australia each have their own registration, importation and advertising rules.
• Advertising rules are usually stricter than sales rules. In most markets you may sell a device long before you may make a health claim about it.
• Medical ozone is not a regulatory status. It describes ozone generated from a pure oxygen feed rather than from ambient air, and says nothing about how a device is classified in your country.

Before you buy

Ask us in writing what applies to your country, and verify the answer independently with your national regulator or medicines authority. If you intend to operate commercially, ask specifically what health claims you may lawfully make in your advertising. Do not treat a manufacturer’s website, including this one, as a regulatory opinion.