Search Results

The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to:

• The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
• The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face writtles.

The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to:

• The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
• The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles
• The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stifficess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

LED FACIAL LIGHT THERAPY MASK (Model: HK207) is a home use wearable LED phototherapy device designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. The red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.

FLEXIBLE LED LIGHT THERAPY (Model: HK209) is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the near-infrared region of the spectrum (880nm) intended to provide topical heating to temporary pain relief. Blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.

The provided document is a 510(k) summary for LED facial light therapy masks (Models HK207 and HK209). It details the device's characteristics and its comparison to predicate devices, but it does not contain information about a clinical study with acceptance criteria and reported device performance in the way typically expected for a diagnostic or AI-powered medical device.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared devices (predicates) by comparing technical, functional, and safety aspects. The "Test Summary" section primarily outlines bench tests conducted to ensure compliance with recognized electrical safety, electromagnetic compatibility, and biocompatibility standards. It explicitly states "Clinic test: N/A".

Therefore, I cannot provide the requested information regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a clinical study from this document.

However, I can extract the information related to the bench testing, which acts as the 'proof' that the device meets safety and performance standards for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance (Bench Tests):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the document explicitly states "Clinic test: N/A" and relies on bench testing and comparison to predicates for safety and effectiveness. Bench tests typically involve testing a representative number of device units (physical samples), not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as no clinical study with human data or ground truth established by experts was reported for this 510(k) submission. For bench testing, expertise would come from engineers, quality assurance personnel, and certified lab technicians according to the relevant standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as no clinical study requiring adjudication of findings was performed or reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is not an AI-powered device, and no MRMC study was conducted or reported.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This is a light therapy device, not an algorithm, and its performance is assessed through its physical and electrical characteristics and light output, not through algorithmic standalone performance.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" is defined by the specific requirements and measurement parameters outlined in the referenced international standards (e.g., ISO 10993, IEC 60601 series). Compliance with these standards indicates satisfactory performance.

8. The sample size for the training set

This information is not applicable as this is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as this is not an AI/machine learning device that requires a training set.

Ask a specific question about this device