#510k
3 articles
At-Home IPL Hair Removal: How the US FDA Record Classifies These Devices
Open the current 510(k) record for Philips Lumea and one line stands out: the product code. Here is what that code establishes, and what it does not.
LED Face Mask Wrinkle Claims: Where the FDA Product Code Puts Them
At-home LED masks and IPL hair removal devices share a regulation number in the United States. What separates them is the product code beneath it — the part marketing usually leaves out.
Volnewmer vs Oligio: What Their FDA Filings Share and Where They Differ
Wontech's Oligio and Classys's Volnewmer both run 6.78MHz monopolar radiofrequency, and both cite the same predicate device in their US 510(k) filings. Line…