(140 days)
The micro current stimulation mode is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
The red light treatment function is intended for the treatment of periorbital wrinkles.
The device consists of three parts: Main unit. Micro current treatment and LED red light treatment attachment. There are two treatment heads for their separate treatment function. The micro current treatment attachment (electrode head) is for micro current stimulation function mode; and the LED red light attachment head is for red light irradiation function mode.
For Micro current stimulation mode:
The device has two electrode connectors for facial stimulation by applying the electrical micro current to electrodes. The output waveform is regulated Voltage of Pulsed Biphasic and provided with 5 steps of output intensity. The device is designed with 5 LED lamps of white color to indicate the output current intensity level. The micro current stimulation requires the use of a conductive gel with FDA clearance during its treatment.
For LED Red light irradiation function:
The device can provide specific photon spectrum by LED for Red irradiation mode. The red light is intended for the treatment of periorbital wrinkles. In Red irradiation mode, the device utilizes Light Emitting Diodes to provide LED light to the body. The red light output is a visible light source of high spectral purity. The output wavelength of Red light is 660 +/- 5 nm, and its power density is about 80mW/ cm2. During the treatment, the user places the treatment head to periorbital area for the treatment of periorbital wrinkle. The LED red light attachment head includes a skin contact sensor that will not allow delivery of light when the treatment head is not contacted with the skin.
When the device is in battery charging, it cannot be operated for treatment. The device is designed with battery status indicating by five pieces of LED lamp on the front of main body of the device:
- When the device is turned on, numbers of these LED lamps on the front of main body will display with blue color for 3 seconds to indicate the batter power level.
- When the battery power is low, the first indicator LED lamp on the front of main body illuminates in orange color.
- Numbers of indicator of these LED lamps will be illuminated in blue color when the battery is in charging, and the number of lamp lighting up will be increasing based on the battery power status during charging. When the battery has been charged fully, the five LED lamps is all light up.
The provided text describes a 510(k) premarket notification for a medical device and evaluates its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance results from a study, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods.
The document focuses on:
- Listing the device's indications for use: "micro current stimulation mode is intended for facial stimulation and is indicated for over-the-counter cosmetic use. The red light treatment function is intended for the treatment of periorbital wrinkles."
- Identifying predicate devices and comparing technological characteristics.
- Listing bench testing performed for safety and performance (e.g., electrical safety, EMC, photobiological safety, software verification, waveform test). These are not clinical performance studies with acceptance criteria as requested in the prompt.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria and a study proving device performance as the provided text does not contain this type of information. The information present is related to regulatory submission for substantial equivalence based on technical specifications and bench testing, not clinical performance studies with human subjects or detailed AI model evaluation metrics.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).