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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.

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