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The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the red and near-infrared spectrum and is intended for the use in the treatment of full-face wrinkles.

The KALA Red Light Face Mask (Model: KALA-01) is an over-the-counter device that is intended to emit energy in the blue region of the light spectrum and is intended for the use in the treatment of mild to moderate acne vulgaris of the face.

KALA Red Light Face Mask is a home wearable light-emitting diode phototherapy device with three proven wavelengths of light 630nm Red light, 830nm Near infrared red light and 465nm blue light, all of these lights are known to treat wrinkles and mild to moderate acne vulgaris of the face. Among them, the device emits energy in red and near-infrared spectrum to treat full-face wrinkles, emits energy in the blue region of the light spectrum to treat mild to moderate acne vulgaris of the face.

The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by Head Straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of silicone.

The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and be connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The KALA Red Light Face Mask cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. Switch the controller ON and allow the mask to run for Red + NIR or Blue modes and 10- or 20-minutes treatment time program. The cable for connecting with the controller is detachable.

The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent.

The provided FDA 510(k) clearance letter and summary for the KALA Red Light Face Mask (KALA-01) primarily focus on non-clinical performance testing and substantial equivalence to predicate devices, rather than a detailed study demonstrating the device meets clinical acceptance criteria.

The document 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 indicates that the regulatory clearance was based on demonstrating the device's technical performance, safety, and similarity to already approved devices, rather than a clinical trial with specific acceptance criteria related to efficacy (e.g., wrinkle reduction or acne treatment efficacy percentages).

Therefore, the following information will be based on the provided non-clinical performance testing and will highlight the absence of clinical study data as explicitly stated in the document.

Acceptance Criteria and Device Performance (Non-Clinical)

Since no clinical study focusing on efficacy endpoints (like wrinkle reduction percentage or acne lesion count reduction) was presented as part of the 510(k) summary, the acceptance criteria and performance reported here are for the non-clinical performance tests conducted to ensure the device's safety and fundamental operational characteristics.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Study Details (Based on Non-Clinical Testing)

As explicitly stated in the 510(k) summary, no clinical testing was performed or required for this clearance. The "study" here refers to the collection of non-clinical tests performed to demonstrate safety and technical performance.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not specify a "sample size" in the context of a patient cohort. For the non-clinical tests, it would typically refer to a statistically relevant number of devices or components tested. This information is not provided in detail, but it's understood that typical engineering and safety tests involve a representative sample of manufactured units or materials.
• Data Provenance: The tests were conducted in a lab setting, likely by the manufacturer or accredited testing facilities. The country of origin for the data (tests) is not explicitly stated beyond the manufacturer being in Shenzhen, China. The nature of these tests is prospective in the sense that they are planned tests on the device or its components to demonstrate compliance with standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• This concept is not applicable to the non-clinical performance and safety tests described. These tests involve objective measurements against established engineering and safety standards (e.g., electrical safety, optical power, material biocompatibility). "Ground truth" in this context is the standard itself (e.g., IEC 60601-1 requirements).
• For biocompatibility, the equivalence relies on the materials being identical to those of a previously cleared device (K202390), implicitly accepting that the ground truth for those materials' biocompatibility was established in the prior clearance.

4. Adjudication Method for the Test Set:

• None in the sense of clinical adjudication by multiple human experts. The compliance for non-clinical tests is determined by adherence to predefined, objective criteria outlined in the relevant international standards (e.g., IEC, ISO). Test reports are typically reviewed by regulatory bodies like the FDA.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for evaluating the performance of diagnostic devices or AI systems where human readers interpret medical images or data. This device is a therapeutic light-emitting mask, and no such study was conducted or presented for its 510(k) clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:

• Not applicable. This device does not involve a diagnostic algorithm or AI for interpretation that would necessitate a "standalone" or "human-in-the-loop" performance evaluation. Its performance is based on its physical emission characteristics and safety features.

7. The Type of Ground Truth Used:

• For the non-clinical tests, the "ground truth" is defined by international safety and performance standards (e.g., IEC 60601 series, IEC 62471, ISO 10993 series) and the specified technical requirements for the device (e.g., power density, leakage current limits).
• For biocompatibility, the ground truth is established by the prior clearance (K202390), based on the assumption that the identical materials have already demonstrated acceptable biocompatibility.

8. The Sample Size for the Training Set:

• Not applicable. The provided documentation does not describe any training set, as it does not involve machine learning or AI models that require specific training data.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there was no training set.

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