Optical diagnostic device for melanoma detection

Optical diagnostic device for melanoma detection is a medical device manufactured by Strata Skin Sciences, Inc.. It received FDA Premarket Approval (PMA) on 2016-08-18 under PMA number P090012. The device is classified under FDA product code OYD. It was reviewed by the SU advisory panel. This device is classified as Class II by the FDA. Class III devices subject to special controls, in addition to general controls. These devices typically require premarket notification (510(k)). PMA is the most stringent type of device marketing application required by the FDA. The device falls under the medical specialty of G. It is regulated under 21 CFR Part 8. Unlike 510(k) clearance, which demonstrates substantial equivalence to a predicate device, PMA requires the manufacturer to submit clinical trial data demonstrating the safety and effectiveness of the device. PMA is generally required for Class III devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury.