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IPL Hair Removal Device is indicated for the removal of unwanted hair. The IPL Hair Removal Device 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.

The subject device IPL Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The IPL Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.

There are BR223, BR225 two models in this application. Their work principle, function, intended use, structure, and composition are the same, with difference being product appearance, but this difference does not affect or change the intended use of the device.

The provided text is a 510(k) summary for an IPL Hair Removal Device (K232939). While it details the device's indications for use, its technical specifications, and a comparison to predicate devices, it does not contain a study report that quantitatively proves the device meets specific acceptance criteria based on performance data.

Instead, the document states: "Performance data supports that the device is safe and as effective as the predicate device for its intended use." It then lists various safety tests (Biocompatibility, Electrical Safety, EMC Safety, Eye Safety, Software Verification and Validation) that were performed and passed to establish substantial equivalence with the predicate device. These are general safety and performance tests required for medical devices, not specific clinical studies demonstrating hair removal efficacy with defined acceptance criteria.

The acceptance criteria for the device are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (iPulse SmoothSkin Gold Hair Removal System, K160968, and IPL Hair Removal Device, K230021). This equivalence is asserted through a comparison of intended use, design, specification, and performance, along with various safety compliance tests.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly addressing the efficacy of hair removal, nor can I provide details on a study that proves the device meets such criteria, as this information is not present in the provided text.

The document implicitly treats the successful completion of the listed safety and performance tests, and the demonstrable similarity to the predicate devices, as meeting the "acceptance criteria" for 510(k) clearance.

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