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IPL Home Use Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

The IPL Home Use 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. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external power adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The IPL Home Use Hair Removal Device includes D-1129, D-1130, D-1119, D-1119, D-1103, D-1176, D-1151, D-T1002 eight models. Their intended use, performance, structure design and operation are basically identical, with the differences contains product appearance, display contents, lamp cartridge's quantity and appearance as well as the placement location of lamp tube; in additional, due to the size of the treatment window in different lamp cartridge, the treatment area (spot size) and output density is a little different; but these differences do not affect or change the intended use of the device.

The provided document describes an FDA 510(k) summary for an IPL Home Use Hair Removal Device. However, it does not contain information about a study proving the device meets specific acceptance criteria related to efficacy (hair removal performance) using human subjects or an AI component.

Instead, the performance data discussed focuses on the following:

• Biocompatibility Testing: Ensuring the materials in contact with the body are safe.
• Electrical Safety and Eye Safety: Adherence to electrical safety standards and photobiological safety standards.
• Software Verification and Validation: For the device's moderate level of concern software.

The document states: "Based on the above performance as documented in this application, the subject device IPL Home Use Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate device." This "effectiveness profile" is likely inferred from the similarity in technological characteristics (like wavelength range, energy density, spot size, pulse duration) to the predicate device, which presumably demonstrated effectiveness in its clearance.

Therefore, I cannot provide the requested table and study details as the document does not present a standalone clinical study with acceptance criteria for hair removal efficacy or an AI component that meets those criteria. The provided information is limited to safety and technical similarity to a predicate device.

If the request was based on a misunderstanding of what information is present in the document, and it's seeking a general outline of what such a response would look like for a hypothetical device with AI and clinical performance data, please let me know.

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