Regulatory

Where we stand with regulators.

Dermosol is a consumer red-light wellness device. We make no claims to diagnose, treat, cure, or prevent any disease. Below is a plain-language summary of the regulatory posture of every Dermosol product.

Device classification

The Dermosol belt is sold as a consumer wellness device. Its red-light emitters operate within IEC 62471 photobiological safety limits for the eye and skin and have been independently tested for compliance.

The protocol claims described on this site are limited to visible cosmetic improvement (fading) of stretch-mark appearance. We do not claim treatment of any medical condition.

Topicals

The Intensifier Serum and Firming Cream are cosmetic skincare products formulated under cGMP at a US-registered facility. Full INCI ingredient lists ship inside the box and are published on each product page.

Safety reporting

If you experience any adverse skin reaction during the protocol, stop sessions immediately and email safety@dermosol.com with photos and a short description. Reports are reviewed by our clinical advisory team and logged in our internal safety registry.

International compliance

The belt is CE-marked for sale in the EU and UKCA-marked for the UK. It complies with FCC Part 15 for the US and ISED RSS-Gen for Canada. Country-specific power adapters are matched to your shipping address.

Questions for our regulatory team?

Email regulatory@dermosol.com.

Contact us