#home device
2 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.