On January 14th, we just get email inform that now we already finished FDA process. Which means Stelle Laser is now FDA approved ! Our diode laser related beauty machines are now FDA approved !
You can check our FDA details in US Food & Drug official website www.fda.gov with 510(k) number of K212478 and get our details! Please see below photo:
Below is the detailed information from FDA:
Except FDA, we have also passed Medical CE issued by TUV.
The 2 most strict and hard to get certificates double ensured our high quality. In whole China no more than 10 companies who have both Medical CE and FDA.