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PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.

PureLift GLOW is a hand-held device intended to apply electrical impulses to strategic locations on the face and Light Emitting Diode (LED) technology that is intended for the treatment of wrinkles and mild to moderate inflammatory acne. The PureLift GLOW probes are designed for optimal contact with the LED technology is not intended to come into contact with the user. The device continually alternates between the positive probes and allows the user to adjust the settings for personalized comfort level by pressing the intensity starts at (1) and continues to (10). The LED treatment area is approximately 36.3cm2 and available five levels of blue (465nm) and red (634nm) wavelengths. The device housing is injection molded of biocompatible thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt rechargeable battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pressed, and a green light illuminates to indicate that the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level to strategic locations on the face and neck with the use of a conductive gel and the LED light is directed to the treatment area.

The document does not contain information regarding acceptance criteria or a study proving the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the PureLift GLOW device, which primarily discusses its substantial equivalence to predicate devices based on technological characteristics and intended use.

While the document states that "Clinical testing was not required to support a substantial equivalence determination" (page 6), it does not describe any specific acceptance criteria for performance metrics (such as sensitivity, specificity, or accuracy for medical devices often associated with AI/ML solutions) nor does it provide details of a study demonstrating the device meets such criteria.

The information provided pertains to bench performance testing to ensure safety and electrical performance, and a comparison table highlighting technological aspects with predicate devices. None of these describe acceptance criteria or a study in the context you've requested.

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