Class II Medical Devices - General and Special Controls:
Medical devices that have to follow special control mechanisms along with general controls because the general controls alone can not be counted on to ensure the effectiveness of the product and its compliance to safety rules. These special controls can be inclusive of post market inspection, specific requirements regarding product labelling and compulsory standards of performance. Prior to their usage, Class II medical devices require assurance that they are safe and will not act as a source of harm to the people who use this device. Class II medical devices are generally known to be non invasive. Some examples of Class II devices are powered wheelchairs, surgical needles, infusion pumps and lasers for example dental lasers, cosmetic lasers as well as lasers used in ophthalmic surgical procedures.