Not all light therapy devices are regulated in the same way. One of the most decisive factors in determining regulatory requirements is risk classification. This classification influences everything from approval timelines and clinical evidence requirements to post-market obligations and market access.

For brands developing light therapy devices, understanding how risk is assessed and what drives classification is essential for building a realistic regulatory and commercial strategy.

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What Risk Classification Means

Risk classification is the process regulators use to assess the potential risk a device poses to users. It considers not only the technology itself, but also how and where the device is used.

Key factors typically include:

• intended purpose and claims
• duration and frequency of use
• level of invasiveness
• energy delivery and biological interaction
• user population (consumer vs professional)

In light therapy, devices may range from low-risk wellness tools to regulated medical devices, depending largely on these elements.

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Risk Classification Under the European MDR

In Europe, medical devices are classified under the Medical Device Regulation (EU 2017/745) using rules set out in Annex VIII. Devices are grouped into Classes I (including sterile and measuring variants), IIa, IIb, or III, based on increasing levels of risk.

(Note: Class I includes subclasses for sterile devices and devices with a measuring function, which may require notified body involvement despite being low-risk.)

For light therapy devices, classification often depends on:

• whether the device delivers energy to the body
• the intended therapeutic purpose
• whether the effect is superficial or deeper tissue interaction

For example:

• A red light panel marketed for "relaxation and mood support" without medical claims may qualify as Class I
• A device claiming "treatment of seasonal affective disorder" would typically fall into Class IIa or IIb due to therapeutic claims
• A high-intensity device for deep tissue photobiomodulation with specific treatment protocols may require Class IIb classification due to energy levels and biological interaction

Many light therapy devices fall into Class IIa or IIb, particularly when making therapeutic claims or when energy delivery may influence biological processes. Higher classes bring increased requirements for clinical evidence, notified body involvement, and post-market surveillance.

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Risk Classification in the United States (FDA)

In the United States, the FDA classifies devices into Class I, II, or III, based on risk and intended use. Each class is linked to a specific regulatory pathway.

For light therapy devices:

• Class I devices are low risk and often exempt from premarket notification (510(k))
• Class II devices typically require 510(k) clearance
• Class III devices require Premarket Approval (PMA)

The FDA evaluates risk through intended use, technological characteristics, and potential hazards. Even non-invasive light therapy devices may fall into higher classes if claims or energy output increase perceived risk.

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Why Classification Has Strategic Consequences

Risk classification directly affects:

• regulatory timelines and costs
• depth of clinical evidence required
• manufacturing and quality system expectations
• post-market obligations and reporting

A higher classification does not mean a product is unsafe, but it does require greater regulatory control and documentation. Misjudging classification early can lead to rework, delayed approvals, or forced changes in claims and positioning.

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Risk Classification Is Not Fixed Forever

Risk classification is not static. Changes in several factors can trigger reclassification:

• Claims: Expanding from wellness to therapeutic indications
• Target users: Shifting from consumer to professional or clinical use
• Treatment protocols: Increasing intensity, duration, or frequency of exposure
• Regulatory interpretation: Updates to guidance documents or classification rules

can all trigger reclassification. This is especially relevant in light therapy, where devices may evolve from wellness positioning to professional or medical applications over time.

Designing products with future classification in mind helps brands scale without starting from scratch.

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Risk-Based Thinking in a Growing Market

As light therapy adoption increases, regulators are applying more consistent and structured risk-based assessments. Devices that clearly define their intended use and manage risk transparently are better positioned for long-term market access.

At Light Tree Ventures, risk classification is addressed from the earliest stages of product development. Devices are designed and manufactured within ISO 13485-certified quality systems, with regulatory expertise guiding classification strategy across both MDR and FDA frameworks.

This approach allows brands to align technology, claims and compliance and to plan realistically for certification, scalability and global expansion.

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Final Thoughts

Risk classification shapes the entire regulatory journey of a light therapy device. It determines how a product is evaluated, approved, and monitored throughout its lifecycle.

Brands that understand and plan for risk early reduce uncertainty, control costs, and build products that are ready for regulated markets.

Because in light therapy, successful innovation depends not only on what a device does but on how its risk is understood and managed.

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References

• European Commission – Medical Device Regulation (EU 2017/745), Annex VIII: Classification Rules
  https://eur-lex.europa.eu/eli/reg/2017/745/oj
• U.S. Food & Drug Administration – Medical Device Classification Overview
  https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device‍
• FDA – Product Classification Database
  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm