Understanding SoClean3+ and FDA Authorization
SoClean products have received considerable attention because they use ozone as part of a supplemental equipment-treatment process.
In August 2024, FDA authorized the SoClean3+ Bacterial Reduction Device through the De Novo pathway. That authorization covers a specific supplemental use and does not mean the device replaces routine cleaning.
What FDA Authorized
FDA classified SoClean3+ as a Class II respiratory accessory microbial reduction device under 21 CFR § 880.6993.
The SoClean3+ is authorized for use as an add-on after regular cleaning to reduce bacteria on certain compatible masks and ventilation hoses.
FDA specifically states that its recommendations regarding regular cleaning have not changed. Users should continue following the cleaning instructions provided by the manufacturer of their equipment.
Supplemental Treatment Does Not Replace Washing
An important distinction is that supplemental bacterial reduction and routine physical washing serve different purposes.
Physical washing helps remove oils, residue, dust, mineral deposits, and other material from washable surfaces. A supplemental bacterial-reduction process is a separate step and does not eliminate the need for regular washing when instructed by the equipment manufacturer.
Users should always follow the care and cleaning instructions supplied with their equipment.
SoClean2 and SoClean3 Recall Information
In November 2023, SoClean announced a voluntary recall involving SoClean2 and SoClean3 equipment.
The corrective action included revised instructions and a hose-and-mask adapter intended to reduce the potential for ozone exposure and help prevent ozone from entering connected equipment.
FDA advised users of affected SoClean2 and SoClean3 products not to use them without the manufacturer-provided hose-and-mask adapter and to follow the revised instructions.
The later FDA authorization of SoClean3+ should not be confused with the earlier SoClean2 and SoClean3 products involved in the recall.
Ozone Considerations
FDA advises consumers to follow equipment-manufacturer instructions regarding the use of ozone or ultraviolet-light products.
FDA's SoClean safety communication also notes that individuals with certain underlying lung conditions or cardiovascular disease may be particularly sensitive to ozone and should consult a healthcare provider before using SoClean equipment.
What SoClean3+ Is Designed to Do
SoClean3+ is designed to provide an additional bacterial-reduction step after regular cleaning of compatible equipment.
Its FDA authorization applies to the specific intended use, conditions, and compatible equipment described in the product's authorized labeling.
Users should review the current SoClean3+ instructions and compatibility information before use.
Washing and Supplemental Treatment Are Different
Routine washing and supplemental bacterial reduction should not be considered interchangeable.
For routine equipment care:
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Follow the manufacturer's cleaning instructions.
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Use only compatible cleaning products and methods.
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Rinse washable items thoroughly when required.
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Allow items to dry completely before reuse.
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Follow the manufacturer's instructions for any supplemental treatment product.
The Bottom Line
FDA authorized SoClean3+ for a specific supplemental use: as an add-on after regular cleaning to reduce bacteria on certain compatible masks and ventilation hoses.
That authorization does not replace the need for routine cleaning.
Consumers should continue following the cleaning and care instructions supplied by their equipment manufacturer and review current FDA and manufacturer information before using any supplemental treatment product.
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