Search Results

• Red light: Treatment of full-face wrinkles.
• Blue light: Treatment of mild to moderate inflammatory acne.
• Red+Blue light: Treatment of mild to moderate inflammatory acne.

The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne for adults in home healthcare environment.

The LED LIGHT MASK adopts light emitting diodes (LED) in the red (635nm ± 5nm) + blue (425 ± 5nm) and red-blue (635nm + 425nm ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect (i.e. treatment of wrinkles and mild to moderate acne. The LED LIGHT MASK adopts the form of a mask that contains 64 LEDs on the inner surface of the main unit. A wired controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). The subject device operates in three treatment modes. One mode emits red light, one mode emits blue light, and the third mode emits red-blue light (i.e. mixed light). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, the user must wear the product before turning it on, then the built-in eye mask of the face mask can block the radiation of LED light to the eyes during each treatment.

The provided FDA 510(k) clearance letter for the LED Light Mask (A093) does not contain any information about acceptance criteria or specific study results proving the device meets these criteria in a performance study with human subjects, AI, or expert adjudication.

The document focuses on:

• Substantial Equivalence: It asserts that the device is substantially equivalent to a predicate device (LED Light Therapy Mask, Model(s): RB-008G/RB-008GB/RB-008J/RB-008JB, K243423).
• Non-Clinical Performance Testing: It lists various safety and performance standards (Biocompatibility, Electrical Safety, Software Verification and Validation) that the device complies with.
• Claim of No Clinical Testing Needed: Section 11.0 explicitly states, "Clinical testing is not needed for this device." This means there was no de novo clinical trial or performance study conducted to establish clinical efficacy for wrinkles or acne beyond demonstrating functional safety and equivalence to a previously cleared device.

Therefore, I cannot fulfill your request for information regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

These elements are typically part of a clinical performance study (often required for devices claiming new indications or significant technological differences), which the manufacturer declared was "not needed" and was therefore not submitted or reviewed by the FDA for this particular 510(k) clearance. The clearance is based on similarity to a predicate device and compliance with relevant safety and performance standards.

Ask a specific question about this device