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

IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed eight models with the same IPL technology for hair removal, which is model DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G. The device 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 activation is by finger switch.

The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.0± 0.25cm2 (Model BDE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-V, DE03B-V, DE03B-G) that is suitable for multiple hair removal areas, such as large areas (e.g. arms, legs) and small areas (e.g. bikini line).

The device contains a skin sensor to detect appropriate skin contact, if the light exit is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which can be activated throughout the whole hair removal process to cool down the treatment area's temperature and provide the user with a better using experience.

The provided text is a 510(k) summary for an IPL Hair Removal Device. It focuses on demonstrating substantial equivalence to predicate devices, but it does not contain information regarding detailed acceptance criteria for hair removal efficacy/safety or the study that proves the device meets such criteria.

The document primarily covers non-clinical performance data related to:

1. Biocompatibility Evaluation: Conducted according to ISO 10993-1.
2. Electrical Safety and EMC: Tested against IEC 60601-1-2, IEC 60601-1, IEC 60601-1-11, and IEC 60601-2-83.
3. Eye Safety: Tested according to IEC 62471.
4. Software Verification and Validation: Documentation consistent with moderate level of concern, demonstrating meeting specifications and mitigating hazards.
5. Usability: Evaluated according to FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."

The document states that the "IPL Hair Removal Device is 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." However, it does not provide any performance data from a clinical study to demonstrate this claim. It explicitly states that "Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use" but immediately follows this by only listing non-clinical testing.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving those criteria are met, as that specific type of data is not present in the provided text.

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