Heb me er niet echt in verdiept, maar kwam deze nieuwe post tegen op baldingblog dat de Lasercomb niet FDA approved is voor de werking maar alleen voor de veiligheid.
http://www.baldingblog.com/2008/05/0...mb-fda-debate/
Citaat:
|
[...]The FDA’s priority is more about safety than effectiveness, and for any 510(k), it should be thought of as simply the FDA giving the manufacturer the go-ahead to proceed to market because it complies with the premarket notification regulations. It should not be assumed that the FDA were satisfied of a high level of efficacy to a high degree of scientific certainty or otherwise.[...]
|