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.
What's in electronic devices? Electronic devices are a complex mixture of several hundred materials. A mobile phone, for example, contains 500 to 1000 components. Many of these contain toxic heavy metals such as lead, mercury, cadmium and beryllium and hazardous chemicals, such as brominated flame retardants. Polluting PVC plastic is also frequently used.