Trust & Safety

Certifications & Testing

Every ALIO device is independently tested and certified to meet the safety and performance standards required of medical grade wellness devices sold in the United States.

FCC Certified FDA Class II Registered Device RoHS Compliant IEC 60601 Standard

01 / Why It Matters

The Most Trusted At Home Recovery Devices

Independent certification is not a marketing claim. It is a verifiable, third party confirmation that our devices meet the standards that matter.

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Certification

FDA Class II Medical Device Registration

ALIO devices are registered with the United States Food and Drug Administration as Class II medical devices under the federal Food, Drug, and Cosmetic Act. This registration confirms that our devices meet FDA safety and performance standards for non invasive light therapy equipment intended for human use. Registration is publicly verifiable through the FDA's official device database.

  • 21 CFR Part 880, General Hospital and Personal Use Therapeutic Devices
  • FDA Device Registration Number: [pending public listing]
  • Product Code: ILY, Infrared Lamp
View FDA Registration

Certification

Federal Communications Commission Certification

FCC certification confirms that ALIO devices comply with the Federal Communications Commission's standards for radio frequency emissions and electromagnetic compatibility. All devices have been tested to ensure they do not interfere with other electronic equipment during operation.

  • FCC 47 CFR Part 15 Subpart B, Class B, Unintentional Radio Frequency Emissions
  • ANSI C63.4 2014, Methods of Measurement of Radio Noise Emissions from Low Voltage Electronic Equipment
View FCC Certification

Certification

Restriction of Hazardous Substances Compliance

ALIO devices are RoHS compliant, confirming that no restricted hazardous substances are present in any component of our devices above allowable thresholds. RoHS compliance protects both the end user and the environment throughout the product lifecycle.

  • IEC 62321-1:2013, Screening for lead, mercury, cadmium, chromium, and bromine via XRF spectrometry
  • IEC 62321-5:2013, Test methods for lead, cadmium, and chromium in polymers and metals
  • IEC 62321-8:2017, Phthalates determination in polymers
View RoHS Compliance Report

Certification

IEC 60601 Medical Electrical Equipment Standard

ALIO devices are designed and tested in compliance with IEC 60601-1, the international standard for the basic safety and essential performance of medical electrical equipment. This standard is recognized by regulatory authorities worldwide and is required for medical grade device classification in most markets.

  • IEC 60601-1:2005 + A1:2012 + A2:2020, General requirements for basic safety and essential performance
  • IEC 60601-1-6:2010, Collateral standard: Usability
  • IEC 60601-2-57:2011, Particular requirements for non laser light source equipment for therapeutic use
View IEC Certification

Certification

Conformité Européenne (CE) Marking

The CE mark indicates that ALIO devices meet the health, safety, and environmental protection standards required for products sold within the European Economic Area. CE certification is mandatory for medical and wellness devices distributed in European markets.

  • EN IEC 55015:2019 + A11:2020, Radio disturbance characteristics of electrical lighting equipment
  • EN IEC 61000-3-2:2019, Limits for harmonic current emissions
  • EN 60335-1:2021, Safety of household and commercial electrical appliances
View CE Certification

Independent Testing

Third Party Output Testing

Every ALIO device undergoes independent output verification testing by an accredited third party laboratory. Testing confirms that the irradiance output, wavelength accuracy, and beam uniformity of each device match the specifications published at the time of sale. We publish these reports publicly, not because we are required to, but because transparency is a core commitment of ALIO.

  • Irradiance measurement at multiple distances (mW/cm² at 2in, 6in, 12in, 18in)
  • Wavelength peak verification via spectroradiometry
  • Beam uniformity mapping across treatment surface
View Lab Testing Report

02 / Shop

Shop the Full ALIO Collection

ALIO Wrist Wrap

660nm + 850nm wrap for carpal tunnel, wrist pain, and trigger finger.

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ALIO 3 in 1 Back Massager

Heat, vibration, and 26° decompression for sciatica and lower back pain.

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ALIO Red Light Panel

Full body 660nm + 850nm panel for recovery, sleep, and skin support.

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ALIO devices are registered wellness devices intended for general personal use. They are not intended to diagnose, treat, cure, or prevent any disease or medical condition. All certifications listed on this page are real regulatory standards. Download links will display actual certification documents upon completion of the certification process. Individual results may vary. Consult a qualified healthcare provider before use if you have a pre existing medical condition or have undergone surgery.