» Should your procedure be FDA approved?

Should your procedure be FDA approved?

Are FDA approved products and devices safer and better than unapproved products and procedures?  This article will examine what an FDA approved device or product means, how to find out whether a device is approved or not, and finally the difference between FDA and unapproved therapies.

FDA approved devices are those that they have been examined by the government and whose benefits will outweigh its risks.  The FDA does not test products, but reviews all of the human and animal studies to determine if it is both a safe and effective product.   

There are two main types of products the FDA will approve.  The 510(k) products are similar or equivalent to products already on the market.  The PMA (PreMarket Approval) devices are those which are different from products already on the market.or just type in http://www.fda.gov.  From this web page, the device is most likely a 510(k) device and if you use the FDA search engine, you should be able to find out more information about the product.  Here you can find out what the product was approved for?  For example, N-lite is a laser approved for facial rejuvenation.  On the report you would not that it is approved for use in the face, neck and around the eyes. 

Some facial products claim to be FDA approved. To verify this, a simple search on the FDA page will allow that.

The real question is whether or not a product or treatment is necessarily better if it has the FDA stamp of approval?  An FDA approved device will allow the customer the assurance that it has met strict government criteria and is considered to be a safe product and reasonably effective.  When considering whether a medical device (such as a type of laser) is approved, it is probably best to stick with an FDA approved treatment.  The one exception would be a physician conducting an approved clinical trial on a device.  FDA approved products, such as facial cleaners and exfoliants, are made to an exacting standard.

 

Contact Us:

312.944.0117
Fill out my online form.