(90 days)
The device is intended to use LED light for the treatment of wrinkles and mild to moderate acne.
The Beauty LED Mask adopts light emitting diodes (LED) in the red (637nm ± 5nm) + infrared (854nm ± 5nm) and blue (465 ± 5nm) spectrum to irradiate on the face to realize its therapeutic effect. The Beauty LED Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). Power adapter is provided to charge the battery contained in the controller. 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, Beauty LED Mask has incorporated protective eye-shield which blocks light energy from LEDs.
The provided document is a 510(k) summary for the Beauty LED Mask, Model: KFB265. It outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain information about clinical studies or specific acceptance criteria and performance data related to its effectiveness in treating wrinkles and acne.
The document primarily focuses on:
- Regulatory classification and product codes.
- Comparison of technological characteristics with predicate devices (e.g., light source, wavelength, power supply, dimensions).
- Compliance with non-clinical standards, such as electrical safety (IEC 60601 series, IEC 62133-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993 series).
- Software verification and validation.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance for clinical outcomes.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method for the test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used (clinical outcomes, pathology, etc.).
- Sample size and ground truth establishment for a training set.
The document states that "Non-clinical testings have been conducted to verify that the Beauty LED Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device." This indicates that the 510(k) clearance was based on demonstrating equivalence in non-clinical technical characteristics and safety, rather than requiring new clinical performance data for effectiveness.
In summary, the provided text describes a regulatory submission based on substantial equivalence to a predicate device through non-clinical testing, not a study proving clinical effectiveness against specific acceptance criteria.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.