I received an e-mail about a new laser device for cellulite. The PR statement hypes its “510(k) FDA Clearance.” I laugh a little. That means the device is so similar to something else already on the market that it does not need more formal FDA approval. Sounds earth shattering…..:)
What is 510K?
The FDA’s 510(k) clearance process is a way for devices (by showing how similar they are to already approved devices) to avoid the more stringent formal FDA PMA process. In essence it is a short cut. So 510K is FDA code for “same old stuff.”
A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA). 510(k) (premarket notification) to FDA is required at least 90 days before marketing…
When I see 510K I read “this device is re-hashed technology to the extent it does not need formal FDA approval.” My already substantial doubt in new devices then climbs to even higher than my usual nuclear cynic level.
People need to know when product literature proclaims FDA approval that it does not mean it works. It generally means that it is at least as safe as other technology on the market.
Now the device can always prove me wrong……
John Di Saia MD
Originally posted 2012-02-02 07:30:21.