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Lumea IPL

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K253754

by Philips Consumer Lifestyle B.V.

Identifiers

510(k) Number
K253754 FDA 510(k)
FDA Product Code
OHT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Lumea IPL is a light-based over-the-counter hair removal device designed for at-home use. It employs intense pulsed light (IPL) technology to target and reduce hair growth on the skin’s surface by selectively absorbing melanin in hair follicles.

Intended for single-use per session, the device is supplied as a non-sterile, reusable handheld unit with interchangeable handpieces. It is classified as Class II under FDA regulations and authorized under the Medical Device Regulation (MDR). The device operates without MRI compatibility considerations and requires proper storage in a dry, temperature-controlled environment to maintain functionality.

Frequently asked questions

What is the Philips Lumea IPL designed to do and how does it work?

The Philips Lumea IPL is an over-the-counter hair removal device intended for at-home use. It uses intense pulsed light (IPL) technology to target and reduce hair growth by selectively absorbing melanin in hair follicles on the skin’s surface. This process helps to weaken and reduce hair over time with repeated sessions.

Is the Philips Lumea IPL reusable or single-use, and what does that mean for maintenance?

The Philips Lumea IPL is a reusable handheld unit, but it is designed for single-use per session. This means the device itself can be used repeatedly across multiple sessions, while the interchangeable handpieces may require replacement depending on usage and manufacturer guidelines. Proper cleaning and storage are essential to maintain functionality and hygiene.

How should I store the Philips Lumea IPL to ensure it remains effective?

The Philips Lumea IPL should be stored in a dry, temperature-controlled environment to preserve its functionality. Avoid exposing it to extreme heat, cold, or moisture, as these conditions could potentially damage the device or affect its performance over time.

What regulatory pathways has the Philips Lumea IPL followed, and what does that mean for its use?

The Philips Lumea IPL has been authorized through both FDA 510(k) clearance and the Medical Device Regulation (MDR) in the EU. It is classified as Class II under FDA regulations, indicating it has undergone evaluation for safety and effectiveness. This means it meets regulatory standards for at-home use, but users should follow the manufacturer’s instructions to ensure proper and safe operation.

Are there any special considerations for using the Philips Lumea IPL, such as MRI compatibility or skin sensitivity?

The Philips Lumea IPL does not require any special considerations related to MRI compatibility, as it is not designed for use in MRI environments. However, it is intended for use on the skin’s surface and should only be applied to areas where hair removal is desired. Users with sensitive skin or medical conditions should consult a healthcare professional before use to ensure safety and suitability.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Philips Consumer Lifestyle B.V.

Sources (2)

  • FDA 510(k) K253754 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026