the Contour Light System, an FDA cleared red light therapy deviceYour clients are curious about red light therapy, but also cautious. They ask you: “Is this treatment safe? Is it effective?” Your answers to these questions can be the difference between a thriving practice and missed opportunities.

As a health and wellness practitioner, you’re dedicated to providing safe, effective, and scientifically-backed treatments. Choosing the right red light therapy device is crucial for upholding these standards. That’s where FDA clearance comes in.

This blog will help you understand the field of professional, medical grade red light therapy devices and the importance of choosing FDA-cleared options like the Contour Light System. We’ll delve into the rigorous testing process, the benefits of clearance, and how it can impact your practice and client relationships.

 

What is the difference between FDA Clearance and FDA Approval for medical devices?

Great question! 

FDA Approval is reserved for Class III medical devices which pose the greatest risk to the patient, like a heart valve or a pacemaker. For Class I and II medical devices with a low to medium risk to the patient, such an LED red light therapy device, the highest award by the FDA is FDA Clearance. Contour Light is in the Class II medical device category. 

The process to gain FDA Clearance is costly, rigorous and meticulous, and it assures the consumer that the device is safe and proven effective. FDA Clearance indicates that a device and provider using the device in their business can legally make claims based on outcomes and benefits as exemplified in the FDA Clearance process. 

It is important to beware of red light therapy devices that may look like Contour Light, but are not FDA Cleared. According to the FDA, a company that makes a medical device that has not completed the process of Clearance, as well as the provider who uses that device in their business, cannot legally make claims of results or even safety. In other words the medical provider and their patients have no way of knowing the quality, nor the efficacy of such a device. In the field of professional red light therapy systems, the pricing is competitive. That means that devices that have not been vetted by the FDA cost the same or close to the same as the one(s) that you can truly count on. 

Contour Light has been awarded FDA Clearance for the effective treatment of several indications including body contouring (circumferential reduction), pain relief, and increased blood circulation. Contour Light continues to seek clearance for other areas of treatment such as skin rejuvenation. accelerated healing, and other proven benefits. They do this for the welfare of the patients, as well as for peace of mind and a legal, viable additional lucrative revenue stream for providers.

 

What Does FDA Clearance Mean for Red Light Therapy Devices?

FDA clearance is the mark of quality and trust. For a red light therapy device to receive FDA clearance, it must undergo extensive testing and evaluation to ensure it meets specific safety and efficacy standards. This process includes rigorous testing for electrical safety, biocompatibility, and performance under various conditions. A medical device can be considered for clearance only when it successfully passes all of these tests.

Contour Light is the only FDA-cleared device of its kind. It features a pad-based, wrap system with red light and near infrared LEDs  that are highly effective and safe for use on nearly the entire body, head to toes. 

 

Why FDA Clearance Matters for Your Practice

Choosing an FDA-cleared red light therapy device like the Contour Light System offers numerous benefits for patients, but also for your practice:

 

  • Client Confidence: FDA clearance serves as a powerful trust signal for your clients. Knowing that their treatment is backed by regulatory approval can alleviate any concerns they may have, leading to increased trust and satisfaction.
  • Proven Safety and Effectiveness: FDA-cleared devices have undergone thorough testing to verify their safety and effectiveness claims. This allows you to confidently market the therapy’s  proven benefits to your clients, knowing they’re backed by scientific evidence.
  • Legal Compliance: Using an FDA-cleared device ensures you comply with legal and regulatory requirements, protecting your practice from potential liabilities.
  • Professional Reputation: Offering this FDA-cleared device enhances your credibility and demonstrates your commitment to providing high-quality, scientifically validated treatments.
  • Competitive Advantage: FDA clearance sets your practice apart, giving you a competitive edge over those offering unproven or uncertified devices.

 

Related Article: How to Start a Red Light Therapy Business

 

The Contour Light FDA-Cleared Advantage

While FDA clearance is essential, Contour Light goes above and beyond to ensure client comfort and safety. Our unique pad-based design allows for targeted, hands-free treatments, minimizing any risk of discomfort or adverse reactions.

Contour Light also stands out for its versatility, offering a range of treatment protocols that can be tailored to each client’s individual needs. Whether your focus is on pain management, skin rejuvenation, or athletic recovery, the Contour Light System is a flexible solution that can enhance your existing services and attract a wider clientele.

 

“Thanks so much for creating this equipment, performing the trials, getting FDA clearance, and offering such a boost to people on weight loss journeys. The Contour Light System has been tremendously helpful to all of our clients who use it. So much so, in fact, that we are contemplating adjusting pricing and adding it as a standard inclusion for all our local weight loss clients because it makes such a difference.”

– Sherene Kershner, Evolve 180 Weight Loss | Bellevue, WA

 

Offer FDA-Cleared Red Light Therapy Devices at Your Practice

By choosing FDA-cleared red light therapy devices like Contour Light, you invest in the future of your practice. You prioritize client safety, enhance your professional reputation, and expand your treatment offerings with confidence.

Ready to experience the difference that FDA-cleared red light therapy can make for your practice? Contact us today for a consultation and discover how Contour Light can elevate your treatments and empower your clients.

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