Laser products that will be marketed in the United States of America must be registered with the CDRH (Center for Devices and Radiological Health), a department belonging to the FDA (U.S. Food and Drug Administration).
Our technical team has gained the methodology and knowledge to import laser devices into United States, following the official procedures of the FDA.
We can take care of the entire technical-administrative process, from preparing the documentation and submitting it to the CDRH to obtaining the accession number corresponding to the registration of your laser product and also the annual maintenance of the registration.
