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What is FDA clearance or approval?

For medical devices, the FDA provides clearance or approval, confirming that a device meets safety and performance standards for use in the USA. Philips Lumea IPL is FDA-cleared for safe at-home use.

Details: The US Food and Drug Administration (FDA) regulates medical devices to help ensure they are safe and effective for their intended use. Rather than offering a general “certification”, the FDA grants clearance or approval based on how a device is evaluated.

For home-use IPL devices such as Philips Lumea, this typically means FDA clearance, which confirms that the device has been reviewed and meets requirements for safety and intended performance. This includes evaluating how the device works, how it is used, and whether it can be used safely outside of a clinical setting.

The information on this page applies to the following models: BRC344/03, BRC332/03, BRI931/03. Click here to show more product numbers  ›

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