Certifications &
Testing
ETL Certified
Class II Medical Device
IEC 60601
The Most Trusted Clinical & Personal Light Therapy Devices
With industry-leading certifications, PlatinumLED ensures every device meets the highest standards for safe, effective light therapy.
SHOP NOWFDA Class II Medical Device registration is a process that ensures that a medical device is safe and effective, and that the organization that produces it can consistently meet the standards of the United States Food and Drug Administration (FDA)
A CanadianMedical Device Licence (MDL)isthe official approval granted by Health Canada allowing manufacturers to sell or import Class II, III, or IV medical devices. It verifies that the product meets strict safety, quality, and effectiveness standards.
Complete, certified output testing performed by accredited lighting industry standard creators, LightLab International
ETL certification, or the ETL Listed Mark, is a product safety certification that indicates a product meets North American safety standards. ETL stands for Electrical Testing Laboratories, and the certification is issued by Intertek, an international certification organization.
ANSI/AAMI ES60601-1:2005+A1;A2 - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-6:2010 Ed.3+A1;A2 - Medical Electrical Equipment – Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.
CSA C22.2#60601-1-6:2011 Ed.3+A1;A2 - Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability.
IEC 60601-2-57:2011 Ed.1 - Medical Electrical Equipment - Part 2-57: Particular Requirements For The Basic Safety And Essential Performance Of Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring And Cosmetic/Aesthetic Use.
CSA C22.2#60601-2-57:2011 Ed.1 - Medical Electrical Equipment – Part 2–57: Particular Requirements for the Basic Safety and Essential Performance of Non-Laser Light Source Equipment Intended for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use.
CE certification, or Conformité Européenne, is a regulatory standard that indicates a product meets EU safety, health, and environmental requirements.
EN IEC 55015:2019 + A11:2020 - Limits and methods of measurement of radio disturbance characteristics of electrical lighting and similar equipment.
EN IEC 61000-3-2:2019 + AI:2021 - Limits for harmonic current emissions.
EN 61000-3-3:2013 + AI:2019 + A2:2021 - Limits for harmonic current emissions.
EN IEC 61547:2023 - Equipment for general lighting purposes. EMC immunity requirements (British Standard).
EN 60335-1:2021 + AC:2014 +A11:2014 + A13:2017 + A1:2019 + A2:2019 + A15:2021 - Safety of electrical appliances for household environment and commercial purposes.
EN 6223:2008 + AC:2008 - Measurement for electromagnetic fields of household appliances and similar apparatus with regard to human exposure.
The CB scheme is an international system for the mutual recognition of test results and certificates in the field of safety of electrical and electronic components, equipment and products based on a multilateral agreement between participating countries and certification organizations.
IEC 60601-1:2005 + A1:2012 + A2:2020: Medical electrical equipment, Part 1: General requirements for basic safety and essential performance.
IEC 60601-1-6:2010 + A1:2013 + A2:2020: General requirements for basic safety and essential performance - Collateral standard: Usability.
IEC 60601-2-57:2011: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
FCC certification is a mandatory requirement in the United States that ensures electronic devices meet the Federal Communications Commission's (FCC) standards for radio frequency interference and electromagnetic compatibility. It's a mark of approval that indicates a product operates within specified parameters and doesn't interfere with other electronic devices.
RoHS certification, or Restriction of Hazardous Substances certification, is a regulation that limits the use of hazardous materials in electrical and electronic equipment (EEE).
IEC 62321-1:2013 - Screening analysis of five substances, specifically lead (Pb), mercury (Hg), cadmium (Cd), total chromium (Cr) and total bromine (Br) in uniform materials found in electrotechnical products, using the analytical technique of X-ray fluorescence (XRF) spectrometry.
IEC 62321-3-1:2013 - screening analysis of five substances, specifically lead (Pb), mercury (Hg), cadmium (Cd), total chromium (Cr) and total bromine (Br) in uniform materials found in electrotechnical products, using the analytical technique of X-ray fluorescence (XRF) spectrometry.
IEC 62321-4:2013 + A1:2017 - Describes the use of four test methods for mercury in polymers, metals and electronics, namely CV-AAS (cold vapour atomic absorption spectrometry), CV-AFS (cold vapour atomic fluorescence spectrometry) ICP-OES (inductively coupled plasma optical.
IEC 62321-5:2013 - Describes the four test methods for lead, cadmium and chromium in polymers, metals and electronics.
IEC 62321-6:2015 - Specifies one normative and two informative techniques for the determination of polybrominated biphenyls (PBB) and diphenyl ethers (PBDE) in polymers of electrotechnical products.
IEC 62321-7-1:2015 - Determination of certain substances in electrotechnical products - Part 7-1: Hexavalent chromium - Presence of hexavalent chromium (Cr(VI)) in colourless and coloured corrosion-protected coatings on metals by the colorimetric method.
IEC 62321-7-2:2017 - Determination of certain substances in electrotechnical products - Part 7-2: Hexavalent chromium - Determination of hexavalent chromium (Cr(VI)) in polymers and electronics by the colorimetric method.
IEC 62321-8:2017 - Determination of certain substances in electrotechnical products - Part 8: Phthalates in polymers by gas chromatography-mass spectrometry (GC-MS), gas chromatography-mass spectrometry using a pyrolyzer/thermal desorption accessory (Py-TD-GC-MS).
IEC 62321-2:2021 - Determination of certain substances in electrotechnical products - Part 2: Disassembly, disjointment and mechanical sample preparation.
Official independent laboratory testing for the SaunaMAX Pro, conducted by LightLab International. These reports verify the system's measured irradiance, spectral output, and overall performance using standardized testing methods, providing transparent validation of product performance.
Find your Fit
BIOMAX PRO Series
With 50% more output and full wavelength control, the BIOMAX PRO sets the standard for red light therapy. It's an FDA Class II Medical Device, proven to deliver faster, deeper results at home.
BIOMAX Series
The flagship that redefined the red light therapy industry. Balanced R+ | NIR+ wavelengths, higher irradiance, and FDA Class II Medical Device Certification make BIOMAX the benchmark for dependable daily recovery.
BIOMAX Go
The most technologically advanced portable red light therapy device.
BIORevive
Engineered to deliver light evenly across the entire head, including areas most helmets miss.
BIORevive PRO
Choose BIORevive PRO if you want the deepest spectrum, the highest output, and settings you can match to your routine.
StudioMax
The first light therapy fixture that treats an entire room. One fixture on the ceiling turns a training floor into a recovery floor.
Mounting Systems
Precision-built hardware designed for stability and control. PlatinumLED mounting systems keep your panels perfectly positioned for consistent coverage and maximum light penetration.
Multi-Light Systems
Expand your reach with modular panels that link together for full-body coverage. Each panel delivers advanced clinical output—scalable, efficient, and engineered for performance at any size.
Saunamax PRO series
Far-infrared heat meets PlatinumLED's red light precision. The SAUNAMAX PRO merges full-spectrum warmth with R+ | NIR+ output for complete relaxation, detox support, and deep-tissue recovery.
