The Optomap allows for a more comfortable retinal exam. Panoramic 200 Retinal Image - Click for hi resolution image. The top image to the right compares the doctor's view of your eye through an undilated pupil with an instrument called a direct ophthalmoscope (inner ring).
Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from Premarket Notification 510(k); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval.
Definition of device for English Language Learners. : 1  an object, machine, or piece of equipment that has been made for some special purpose. : 2  a weapon that explodes. : 3  something that is done in order to achieve a particular effect.