TheraLight 360 HD & TheraLight FIT Specs Compared to:  
 

Are you being told a light bed has to be FDA approved or cleared?

The truth is, it doesn't. The FDA approves drugs, not devices. If a product has an FDA "clearance" it means they proved that the device can cause a change in form or function within the body. Example: decreases fat or reduces pain. These are medical claims and must be proven. Bed makers are not required to get a clearance, but they cannot make a specific claim without one unless, in the case of light beds, they piggy-back on similar predicate devices.  The facts & references are below if you would like to learn more. Aspen's 30 year history with class 4 laser expertise has culminated in a world-class light bed utilizing proven multiple wavelengths in a 360 HD pod delivering results faster than ever before. Learn more

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FACTS:
There are instances where certain general wellness products do not meet the definition of a device under section 201(h) of the FD&C Act and therefore are not subject to the FD&C Act’s regulatory requirements for devices.  Meaning, they do NOT require FDA Clearance or 510(k) Clearance.   Instead, these devices are simply "registered" with the FDA as General Wellness Products.

 

In JULY of 2016, the FDA has created a guidance document to describe their current thinking on the topic of Low Risk/General Wellness Devices.  The document is called General Wellness: Policy for Low Risk Devices and can be found on the FDA.gov website.  Please refer to that document for full details.  The following is a brief overview.

 

The Center for Devices and Radiological Health defines general wellness products as products that meet the following two factors:  

• intended for only general wellness use and 

• present a very low risk to users’ safety

 

To be considered a general wellness product, a device has to have:

• an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity

  • Claims cannot make any reference to diseases or conditions

• an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

 

If the product’s intended uses are not limited to the above general wellness intended uses, this guidance does not apply.

 

To be considered a LOW RISK device, the product cannot:

• be invasive

• involve an intervention or technology that may pose a risk to a user’s safety if device controls are not applied

• raise novel questions of usability

• raise questions of biocompatibility

 

The ASPEN TheraLight Pod qualifies as a General Wellness Device based on the criteria outlined,  and is classified under FDA 21 CFR 890.5350, Exercise Component, product code IOD

 

The Class I Intended Uses of the Aspen TheraLight Pod are as follows:

• Restoration of motion to joints

• Redevelop muscles

• Adjunct to obesity as part of a diet and exercise program

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TheraLight is a registered trademark of Aspen Laser Systems, LLC. Light Stim is a registered trademark of LED Intellectual Properties, LLC. . NovoTHOR is a registered trademark of THOR Photo Medicine, Ltd. Aarc, Prism & Envy are also trademarks of independent companies and are not associated to any companies listed here. 

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