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Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Philips Lumea IPL is an Intense Pulsed Light (IPL) device intended for removal of unwanted hair. The device is to be used by persons in the age range of 18-65 years with fair up to medium brown skin tones, and naturally dark blond, brown, dark brown and black hair.

The Philips Lumea IPL applies spectrally adjusted light to the user skin, which is absorbed by the melanin and after some applications hair sheds naturally and growth is delayed or inhibited.

The Philips Lumea IPL is an Over-the-counter hand-held device powered by a wall mount adapter. It is provided in a non-sterile state and intended to be used by single person for multiple uses in homecare environment.

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Philips Lumea IPL is indicated for the removal of unwanted hair for a single user. It is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

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This document is a 510(k) clearance letter from the FDA for the Philips Lumea IPL device. It does not contain any information about acceptance criteria or a study proving that an AI/software device meets acceptance criteria.

The letter primarily covers:

• The FDA's review and determination of substantial equivalence for the Philips Lumea IPL.
• Regulatory information and requirements for marketing the device.
• The device's indications for use: "removal of unwanted hair for a single user" and "permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime."
• The device is for Over-The-Counter Use.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving a device meets them, as the provided text doesn't concern an AI/software device or its performance study.

Ask a specific question about this device