Are There Any FDA Warnings Regarding Capillus Laser Cap Products?

The safety and efficacy of medical devices are of utmost importance to the Food and Drug Administration (FDA). When it comes to Capillus Laser Cap products used for hair regrowth, it is crucial to understand whether there have been any FDA warnings associated with these devices. By examining the FDA’s stance on Capillus Laser Cap products, we can gain valuable insights into their safety and potential risks.

About the Capillus Products

The Capillus82, 202, and 272Pro are similar to baseball caps with internal laser-emitting diodes arranged in a row; the only distinction is the number of diodes. According to the company’s website, “laser therapy caps” use “safe, low-level lasers” that are said to “energize hair follicles and spur new, natural hair growth.” Both men and women are targeted by product marketing. The manufacturer’s guarantee for the Capillus82 is now one year; the warranty durations for the more expensive variants are longer.

How are Capillus Laser Caps Supposed to Work?

Capillus laser caps work through low-level laser therapy technology, which is designed to stimulate hair follicles at a cellular level, to energize them and promote new, natural hair growth. The caps are equipped with a specific number of laser diodes, and the higher the number of diodes, the higher the cap price. Additionally, the caps are powered by a lithium-ion battery pack, allowing for convenient and portable use.

Are there any FDA warnings regarding Capillus Laser Cap products?

Yes, there are FDA warnings regarding Capillus laser cap products. The National Advertising Division (NAD) of the Better Business Bureau recommended in September 2017 that Capillus discontinue certain claims about their products that were not supported by clinical studies, even though the products had been FDA-approved. Additionally, there have been consumer complaints about the effectiveness and cost of the products. The False Claims Act allows consumers to pursue litigation against companies that made claims about their products that turn out to be misleading, exaggerated, untrue, or even unsafe. Therefore, there are concerns and warnings related to Capillus laser cap products.

What is an FDA Clearance and why is it important?

An FDA premarket notification, or 510(k), is submitted to show the safety and efficacy of a device. The Food & Drug Administration must approve a medical device before it may be sold lawfully in the US. The FDA must receive an application from the device’s producer before clearance can be granted. This application may contain efficacy-proving clinical studies, safety data, and other proof that the device is safe and effective for the purposes for which it was designed. Both doctors and patients should be informed of the risks and hazards involved in buying a product without FDA approval.

Is FDA clearance approved for Capillus LLLT devices?

The FDA clearance for Capillus low-level laser therapy (LLLT) devices is a point of contention. While Capillus maintains that their products have received FDA clearance, this clearance was not based on clinical studies of the product itself, but rather on a “predicate” device already in the market, the HairMax Laser Comb. The FDA’s 510(k) Premarket Notification process, through which Capillus gained approval, does not require clinical testing but rather demonstrates substantial equivalence to a previously FDA-approved device.

This approval process has been criticized, as it has led to the clearance of other medical devices that have later been found to be problematic. Additionally, there are questions about the clinical study cited by Capillus to support their claims of hair regrowth, as it involved only female subjects and used a device from a different manufacturer. These factors raise concerns about the FDA clearance of Capillus LLLT devices and highlight the need for further scrutiny.

What’s the difference between FDA approval and FDA clearance for medical devices and drugs?

Only medications and medical devices classified as Class III (i.e., implanted, life-threatening, life-sustaining, or presenting an unreasonable risk of injury or illness) or newly developed products with novel materials or distinct designs from those already on the market are granted “Approvals” by the FDA.

The FDA only gives “clearance” (pre-market approval) to commercialize a novel medical device that is essentially equivalent to one that already has FDA approval for the same intended application and similar technical qualities. Capillus laser devices were not a candidate for the FDA approval procedure because they were essentially the same as devices available in the market.

Is Physician Recommended Capillus Products?

The claim of Capillus products being “physician recommended” has been brought into question, particularly in the case of the Capillus82. The National Advertising Division (NAD) raised concerns about this assertion, as it was solely based on testimonials from specialists in hair restoration. This reliance on testimonials rather than clinical evidence has led to scrutiny over the validity of the “physician-recommended” label for Capillus products.

Consumer Complaints About Capillus

Regarding the Capillus devices, users have also got a lot to say. In reality, a significant portion of its product reviews on Amazon and other review sites are one-star ratings, with customers claiming the device is a fraud, worthless, and way too pricey for what it does. The assumption that low-level laser devices such as the Capillus caps are as effective as advertised is not well-supported by the available data.

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Conclusion

Maintaining a thorough understanding of any FDA warnings regarding medical devices such as Capillus Laser Cap products is essential. This enables individuals to make informed decisions about their healthcare and hair regrowth options. By staying updated on potential risks or warnings, individuals can ensure their well-being and make choices that align with their needs and preferences.