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Regulatory Notice

This notice explains the regulatory status of the documentation referred to on this website and what it does and does not represent.

Product classification

The Luxis plasma skin care system is a professional beauty and aesthetic care device. Product classification and permitted claims vary by country and must be confirmed for each market before the product is promoted there.

The supplied verification document

Korea Luxis Tech holds a voluntary verification document relating to the Luxis plasma skin care system range.

  • Directives covered: LVD 2014/35/EU and EMC 2014/30/EU.
  • Referenced standards: EN 60335-1:2012+A15:2021, EN IEC 55014-1:2021, EN IEC 55014-2:2021.
  • Product models listed: SUS-K, SUS-L, SUS-T, SUS-P, SUS-S.
  • Document number ICR/VC/HM2503101, issued 12 March 2025, expiring 11 March 2030.

What the document does not represent

The document is a voluntary verification of the electrical safety and electromagnetic compatibility aspects it covers. It is not a medical-device certification and it does not imply conformity with all essential requirements of any directive or regulation.

  • It is not an EU medical-device CE certificate.
  • It is not FDA clearance, approval or registration.
  • It does not establish a medical indication for acne, eczema, dermatitis, wounds, fungal infection or alopecia.
  • It does not substantiate antibacterial reduction percentages or clinical efficacy figures.

Claims policy

Product information on this website uses appearance-focused wording such as “supports”, “designed to” and “helps improve the appearance of”, and describes professional care protocols rather than medical treatment.

  • We do not use “cures”, “treats disease”, “heals”, “sterilises”, “medical-grade”, “clinically proven” or “FDA approved”.
  • We do not display a generic “CE Approved” badge.
  • Product documentation is provided to qualified partners for evaluation purposes only.

Availability by market

Regulatory classifications, permitted claims, and market availability vary by country. Contact Korea Luxis Tech for documentation applicable to your market.

Professional use

The system is intended for trained professional use in a professional beauty or aesthetic environment, following the product instructions and the requirements of the country of sale.