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

IPL Hair Removal Device is an over-the-counter, light based device for unwanted hair removal by using Intense Pulsed Light (IPL) technology. The device works below the skin's surface and does not involve any culling, removing hair growth with minimal pain.

The device includes three models with the only difference in enclosure color. It is only power adapter and its PL emission activation is by a switch or auto light emission, and it contains a skin sensor to detect appropriate skin contact, if the flash window is not in full contact with the skin, the device cannot emit the treatment light pulses. The device has a sapplire cooling function for a better hair removal experience.

This document is a 510(k) premarket notification for an IPL Hair Removal Device (BE965A, BE965B, BE965C). It states that non-clinical testing was conducted to verify that the device meets all design specifications and is substantially equivalent to predicate devices. However, the document explicitly says:

"The clinical test is not applicable, there's no clinical data."

Therefore, I cannot provide information on acceptance criteria and a study that proves the device meets clinical acceptance criteria, as no clinical study was performed or cited in this document.

The document focuses on demonstrating substantial equivalence through non-clinical testing against a set of established electrical, safety, and biocompatibility standards. It does not contain information on device performance in terms of hair removal efficacy or safety as evaluated in a clinical setting with human subjects.

As a result, I cannot provide a table of acceptance criteria and reported device performance from a clinical study, nor specific details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies for clinical performance.

The document instead lists various international standards that the device complies with, which relate to electrical safety, electromagnetic compatibility, home healthcare environments, home light therapy equipment, photobiological safety, usability, and biocompatibility.

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