This post is in response to an email announcement from Formlabs stating “Form 2 FDA-Cleared for 3D Printed Diagnostic Models”, where it also says “…the Form 2 is the first and only stereolithography 3D printer validated by Materialise and approved by the FDA for printing diagnostic models.”
I see that Materialise has validated the Form 2, and that Materialise has 510(k) clearance for their software, but I don’t see any documentation that the Form 2 has been approved (or more likely cleared) by the FDA. Just looking for some clarity here.
The Form 2 is not a medical device.
A separate company, Materialise, has a medical device (their diagnostic models) that they use the Form 2 to print. They have validated their process for making these models using the Form 2. This does not make the Form 2 necessarily appropriate for any other medical uses.
As a separate comment, the Form 2 has biocompatibility data for some of their resins (dental use). This can help greatly if you want to use something fabricated from those resins in a medical device. But again - there is no FDA clearance for the Form 2 or any of their resins.
I understand and agree with what you are saying, however Formlabs said in that email what I have quoted above, which clearly states they are claiming FDA approval or clearance on the Form 2.
Their wording is not incorrect, but is very narrow in scope.