Light therapy devices are often positioned at the intersection of wellness and medical use.
While this creates broad commercial opportunities, it also introduces regulatory complexity.
The difference between wellness claims and medical claims is not just semantic, it directly determines how a device is regulated, approved and marketed.

Understanding where this boundary lies is essential for brands that want to grow without facing regulatory reclassification, forced relabeling or market withdrawal.

‍

What Defines a Wellness Claim?

Wellness claims typically relate to general wellbeing or lifestyle support and avoid references to diagnosis, treatment, or prevention of disease.

Common wellness claims in light therapy include:

• supporting relaxation or recovery
• promoting skin appearance or vitality
• enhancing general comfort or wellbeing
• supporting normal physiological processes

Devices making only wellness claims may face lighter regulatory requirements, depending on region. However, this does not mean such products are unregulated: safety, quality and truthful communication remain mandatory.

FDA General Wellness Criteria

Under the FDA General Wellness: Policy for Low Risk Devices, a product may qualify as a general wellness device if it meets both of the following criteria:

1. The claim relates only to general wellness, such as:
   
   • maintaining or encouraging a healthy lifestyle
   • supporting general wellbeing
   • reducing stress or promoting relaxation (without referencing a disease)
2. The device presents low risk to the user, meaning it is:
   
   • non-invasive
   • does not pose significant safety concerns
   • used in a manner consistent with consumer wellness products

If a light therapy device exceeds these criteria through claims, implied benefits, or clinical framing, it may fall outside the General Wellness category and require FDA medical device clearance.

‍

What Turns a Claim into a Medical Claim?

A claim becomes medical when it implies that a device:

• treats or alleviates a disease or condition
• affects a pathological process
• prevents or manages a medical disorder
• provides therapeutic outcomes

In light therapy, even subtle wording can shift a product into medical territory. Claims related to pain reduction, inflammation control, tissue healing, or neurological effects often trigger medical device classification under MDR or FDA rules.

Concrete Wording Examples

‍

Wellness positioning

Medical claim

“Supports relaxation and general wellbeing”

“Treats anxiety and stress disorders”

“Promotes healthy-looking skin”

“Reduces wrinkles and treats acne”

“Supports natural recovery processes”

“Accelerates wound healing and tissue repair”

“Helps maintain joint comfort”

“Treats arthritis and joint inflammation”

“Supports muscle recovery after activity”

“Reduces chronic muscle pain”

‍

Even terms like “therapeutic,” “clinical,” “treatment,” or naming specific medical conditions in marketing materials can trigger medical classification, regardless of what the device technically does.

‍

Why the Distinction Matters

The difference between wellness and medical claims directly affects:

• regulatory classification and approval pathway
• clinical evidence requirements
• labeling and instructions for use
• post-market surveillance obligations

A device marketed as wellness but interpreted as medical by regulators can be subject to enforcement actions, market removal or mandatory reclassification.

‍

Regulatory Perspectives: MDR and FDA

European Union – MDR and Borderline Guidance

Under the European MDR, intended purpose and claims are decisive for classification. Even non-invasive devices can qualify as medical devices if claims imply therapeutic benefit.

The MDCG 2022-5 guidance on borderline products clarifies that:

• marketing language, website content and distributor materials all contribute to intended purpose
• borderline products are assessed conservatively when claims suggest medical benefit
• ambiguity often leads to medical classification rather than exemption

The EU Borderline Manual further emphasizes that “supporting recovery”, “reducing pain”, or “improving function”may be interpreted as medical if not clearly framed within normal physiology.

‍

United States – FDA Intended Use

In the United States, the FDA evaluates devices based on intended use, derived from:

• labeling and instructions
• promotional materials
• online content

Devices that exceed general wellness claims may require clearance through:

• 510(k)
• De Novo
• PMA

In both systems, regulators assess what the device is claimed to do, not how the manufacturer internally categorizes it.

‍

Strategic Claim Positioning

For light therapy brands, claim strategy should be defined early and supported consistently across:

• marketing materials
• packaging and manuals
• distributor training
• digital content

Strategic positioning typically follows one of two paths:

Wellness-focused strategy

• faster market access
• lower regulatory burden
• limited therapeutic claims

Medical-focused strategy

• higher evidence requirements
• access to professional channels
• potential reimbursement opportunities

Problems arise when brands unintentionally mix both approaches. A single medical-leaning claim can override an otherwise wellness-based strategy and trigger full medical device obligations.

‍

Consequences of Misclassification

Misclassification is not a theoretical risk. Real-world consequences include:

• forced relabeling and claim removal
• withdrawal from specific markets
• regulatory enforcement actions
• delays in commercialization
• reputational damage with distributors and regulators

Correcting misclassification after market entry is often significantly more costly than defining a compliant claim strategy upfront.

‍

Claim Clarity in an Evolving Market

As light therapy adoption grows, regulators are paying closer attention to borderline claims. Devices that clearly define their intended use and stay within justified boundaries are less likely to face regulatory challenges.

At Light Tree Ventures, claim strategy is considered an integral part of product development. Devices are developed and manufactured within ISO 13485-certified quality systems, with regulatory expertise guiding claim definition, evidence alignment and market positioning.

This ensures light therapy devices are positioned clearly, whether in the wellness or medical category, while remaining compliant with MDR and FDA requirements.

‍

Final Thoughts

Wellness and medical claims may appear similar, but they carry very different regulatory consequences. In light therapy, precision in language is as important as precision in technology.

Brands that define and support their claims early reduce risk, maintain credibility and create products that can scale across markets with confidence.

Because in regulated industries, success begins with clarity of purpose and proof.

‍

References

• U.S. Food & Drug Administration – General Wellness: Policy for Low Risk Devices
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices  
• U.S. Food & Drug Administration – General Wellness: Policy for Low Risk Devices (2016, still in force)
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices
• Kramer, D.B., Xu, S., & Kesselheim, A.S. (2012). How Does Medical Device Regulation Perform in the United States and the European Union?
  PLoS Medicine
  https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1001276
• Hamblin, M.R. (2017). Photobiomodulation or Low-Level Laser Therapy.
  Journal of Biophotonics
  https://onlinelibrary.wiley.com/doi/10.1002/jbio.201700113

‍