Barb,
You need to check the indications for use for this device. For different applications, such as details of your specific procedures, this can be Class 2 or Class 3 device. In addition, what type of "limitations" this device posibly create? What is the design changes from prior device?
FDA will consider device that monitor eye movement as Class 2, but ophthalmic suture is Class 3. Do you have enough information?
In reference to SIMCO? word, I know some devices required "registration" prio to ANY use. This can be this type of device.
Hope this will help,
Mike