Product Code PSN

margadia

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Does anyone have an insight into devices listed under product code PSN? It is defined as light-based imaging and all devices with 510k's listed under this product code suggest they are intended for diagnostic screening of suspicious lesions, which makes sense that they would be considered a Class II device requiring 510k submission. But I'm interested in learning if a substantially equivalent device is not intended for diagnostic purposes, but rather to make comparisons of skin through before and after images, would it still be considered a Class II device requiring 510k? All feedback is appreciated. Thanks!
 
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