Search Results

The EmoLED device is intended to provide photo therapeutic light to the body. The EmoLED device is generally indicated to treat dermatological conditions. The EmoLED device is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.

Emol.ED is a portable, reusable medical device powered by rechargeable lithium-ion batteries that illuminate six (6) LED light sources which emit non-coherent blue light between 415 ± 5 nanometers (nm). The EmoLED device emits a uniform and constant optical power intensity of 120 mW/cm2 over an area of approx. 50.3 cm in diameter) at a distance of 4 +/- 1 cm. The EmoLED device consists of:
a polycarbonate body containing a software-controlled processor that controls the emission of light; .
a touch screen (display), placed in the front part of the device that allows the operator to control the device;
a multi-function (on/off) button, placed in the posterior part of the body of the device;
a power jack and a micro-USB plug, placed on the left side of the body of the device;
an optic part containing the LED light source, the LED's control board, an optical lens (optic head) and a distance sensor connected to the body which can be rotated by the operator up to 180° to project the light beam on the desired skin surface;
accessories, which include a visual comfort screen and 24V power supply (with an integrated connection cable).

The provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria for the EmoLED device. The document is a 510(k) premarket notification letter from the FDA, a 510(k) summary, and an Indications for Use statement.

It primarily focuses on:

• Regulatory clearance: The FDA's determination of substantial equivalence for the EmoLED device to legally marketed predicate devices.
• Device description: Details about the EmoLED device's components, light emission, power, and treatment area.
• Indications for Use: Specifically, to treat moderate inflammatory acne vulgaris using visible blue/violet light.
• Comparison to predicate devices: Discussion of technological similarities and differences with predicate devices (Dermalux Tri-Wave MD and BLU TOTALE) regarding wavelength, power density, treatment area, dosage, and treatment time, arguing that these differences do not raise new questions of safety and effectiveness.
• Non-clinical testing: A list of standards to which the device was tested (IEC 62471, IEC 60601-2-57, IEC 62366-1, CEI EN 60601-1-6/A1:2016, ISTA 3E 2017) to verify design specifications and demonstrate safety and effectiveness.
• Absence of clinical testing: Explicitly states, "No clinical testing has been performed to support this submission."

Therefore, based only on the provided text, I cannot furnish the requested information regarding acceptance criteria, reported performance, sample sizes, ground truth establishment, or any MRMC studies. The document only mentions that the device met design specifications and complied with listed non-clinical testing standards.

Ask a specific question about this device