Search Results

KFB290, KFB291:
Red light: Treatment of full-face wrinkles.
Infrared light: Provide topical heating for the purpose of elevating tissue temperature; arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
Red+Infrared Light: Treatment of full-face wrinkles.
Amber light: Treatment of full-face wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Mixed light(Red+Blue +Infrared): Treatment of mild to moderate inflammatory acne.

KFB265, KFB293:
Red+Infrared Light: Treatment of wrinkles.
Blue light: Treatment of mild to moderate inflammatory acne.
Amber light: Treatment of wrinkles.

KFB290, KFB291:
LED Light Therapy Device(Models: KFB290, KFB291) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, Silicone eye protector, USB charging cable and straps. The LED Light Therapy Device have 4 kinds of light, which include Red light (wavelength 635nm ± 5mm), Blue light (wavelength 465 ± 5nm), Infrared light (wavelength 850mm ± 5mm), Amber light (wavelength 605 ± 5nm).

KFB 265, KFB 293:
LED Light Therapy Device(Models: KFB 265, KFB 293) is a home use wearable LED phototherapy device which can help reduce wrinkles and acne and provide topical heating. LED Light Therapy Device is consisting of main unit(mask), controller, USB charging cable and adapter. There are several kinds of light having medical effects: Red + Infrared (wavelength 637nm (±5nm), Blue light (wavelength 465nm), Amber light (wavelength 605±5nm).

This section provides information about the acceptance criteria and the study that proves the device meets those criteria for the LED Light Therapy Device (Models: KFB290, KFB291, KFB265, KFB293).

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document details non-clinical performance data (biocompatibility, electrical safety, eye safety, and software verification/validation) and structural equivalence to predicate devices, rather than specific quantitative acceptance criteria for therapeutic efficacy tied to a clinical study. The device is cleared based on demonstrating substantial equivalence to predicate devices, implying that its performance is comparable and acceptable for the stated indications.

The acceptance criteria here are implicitly met by demonstrating compliance with recognized standards and similarity to legally marketed devices.

• IEC 60601-1:2005+A1:2012+A2:2020 (General requirements for basic safety and essential performance)
• IEC 60601-1-2:2014+A1:2020 (Electromagnetic disturbances)
• IEC 60601-1-11:2015+A1:2020 (Home healthcare environment)
• IEC 60601-2-83:2019+A1:2022 (Home light therapy equipment)
• IEC 60601-2-57:2011 (Non-laser light source equipment for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use)
• IEC 62133-2:2017 (Secondary cells and batteries safety) |
  | Eye Safety | Compliance with IEC 62471:2006 (Photobiological safety of lamps and lamp systems). |
  | Software Verification and Validation | Consistent with a moderate level of concern. System validation testing demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. |
  | Technological Characteristics and Intended Use | Demonstrated to have the same intended use and similar technological characteristics, features, specifications, and materials as legally marketed predicate devices (K223544, K230351, K162489, K221151). Minor differences do not raise safety or efficacy issues. |

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

The provided document describes non-clinical performance data and a comparison to predicate devices, not clinical studies with human test sets. Therefore, details regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable in this context. The evaluation relies on standardized testing (e.g., ISO, IEC) and technical comparisons.

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

This information is not applicable as the submission focuses on non-clinical performance and substantial equivalence based on technical comparisons and compliance with recognized standards, rather than a clinical study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3.

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:

An MRMC comparative effectiveness study was not conducted or described in the provided document. The device is an LED Light Therapy Device, not an AI-assisted diagnostic or interpretable imaging device for human readers.

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

A "standalone" performance evaluation in the context of an algorithm or AI was not performed or described. This device is a direct-use LED therapy device.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is based on:

• Compliance with recognized international standards: (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical and medical device safety, IEC 62471 for photobiological safety).
• Substantial equivalence to legally marketed predicate devices: The predicate devices themselves have established a safety and effectiveness profile for the indications.

There is no mention of expert consensus, pathology, or outcomes data from a clinical trial for establishing ground truth regarding therapeutic efficacy for this submission.

8. The Sample Size for the Training Set:

This information is not applicable as the submission is for a phototherapy device, not an AI/machine learning algorithm requiring a training set.

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

This information is not applicable for the same reasons as point 8.

Ask a specific question about this device