Why We Are Only Using Medical Devices That Are Only FDA Approved, Not Registered Or Cleared

Why We Only Use FDA Approved Lasers

Want to know why we only ever use FDA Approved lasers for our cosmetic and beauty treatments? Well, it all comes down to how seriously we take client safety – here's what you should know.  

What Is the FDA?

First, let's be clear on how the FDA works. 

The Food & Drug Administration, or FDA, protects public health by controlling who can sell medical devices in the US. So, all companies must be registered with the FDA before they can start selling medical products to a US audience.  

Being FDA Registered, however, does not mean that any medical device sold by the company is fit for purpose or safe for its intended use. It simply means that the company can sell medical devices in the US. 

Does the FDA Regulate Lasers?

Yes. Lasers can emit a small amount of electronic radiation, which means they're subject to FDA scrutiny. The FDA will inspect laser devices to ensure they comply with federal safety standards, and they'll recall lasers that have safety defects.  

Does this mean that all medical lasers used in the US are safe, then? 

Not necessarily – here's why. 

FDA Approved vs. FDA Cleared Lasers

To ensure a laser is safe, it must be FDA Approved. FDA Approved devices undergo vigorous safety checks and inspections to ensure they're fit for their intended purpose before they go to market. 

If a laser is "FDA Cleared," on the other hand, it just means that it's similar to an FDA Approved laser. It doesn't mean that it's as safe as the FDA Approved laser – only that they're similar. 

Lasers Imported from Abroad

If you buy medical lasers from abroad, there's a chance the manufacturer will not be FDA registered. In other words, the FDA hasn't approved the laser or inspected it for safety defects. 

Best case scenario? The laser just isn't very effective. In the worst case, however, it could seriously harm the client. It could also severely damage your reputation as a health or wellness professional.  

Takeaway

We never use devices from manufacturers who are not FDA Registered as doing so could put our clients at risk. And, to ensure the medical devices we use are safe and actually fit for their intended purpose, we only ever use FDA Approved lasers for our treatments.    

For more information on how to check whether a medical device is FDA Registered, search for the manufacturer over on the FDA's Registration & Listing Database.