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The LED Eye mask (Model: EY-20R, A20, EY-20N) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.

The LED Eye Mask, model: EY-20R, A20, EY-20N is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the main unit. USB cable cord and velcro straps and removable eve protection. There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm². The device has only one button to turn on/off. The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment. There are no differences between the three models other than the appearance.

I am sorry, but the provided text from the FDA 510(k) summary for the LED Eye Mask (K233556) does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria for its intended use of treating wrinkles.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K221444) by comparing design principles, intended use, functions, materials, and applicable standards.

Here's what the document does include, and why it doesn't answer your specific questions:

• Non-Clinical Tests: The document lists several non-clinical tests performed, such as electrical safety, electromagnetic compatibility, biocompatibility, software verification/validation, and usability validation. These tests confirm the device's electrical safety, material compatibility, and user-friendliness, but they do not directly assess the clinical effectiveness of reducing wrinkles.
• No Clinical Study Mentioned: Crucially, Section 7.2 explicitly states: "Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively." This means no clinical study was conducted for this specific 510(k) submission to prove its effectiveness in treating wrinkles. The substantial equivalence argument relies on the predicate device having demonstrated effectiveness, and the new device being sufficiently similar not to raise new safety or effectiveness concerns.

Therefore, I cannot provide the information you requested about acceptance criteria and a study proving clinical effectiveness, as it is not present in the provided FDA 510(k) summary. The document focuses on regulatory compliance through substantial equivalence, rather than directly showing new clinical efficacy data.

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