(185 days)
The red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
The LED Phototherapy Device (Model: PL-120) directly applies photon light onto skin surface by making using of specific photon spectrum. Each device is equipped with two LED lamp holder, one is emitting blue light which wavelength at 415nm±3nm. The other lamp emits red light which wavelength at 630nm±3nm. The red light is intended for the treatment of periorbital wrinkles. The blue light is intended for the treatment of the mild to moderate inflammatory acne. The user can change the treatment lamp according to their own needs. It employed a 3.7 V Li-ion battery to provide power, and the internal battery is rechargeable. And the device has five options for setting the auto-off time, as below table listed:
The provided document is a 510(k) summary for a medical device (LED Phototherapy Device) seeking substantial equivalence to predicate devices. It describes the device, its intended use, and test summaries for safety and performance. However, this document does not contain information about a clinical study involving human patients, multi-reader multi-case (MRMC) studies, or the use of AI.
The "Test Summary" section explicitly states that the device's safety and performance were evaluated by lab bench testing according to various IEC (International Electrotechnical Commission) standards for electrical safety, electromagnetic compatibility, and photobiological safety, as well as software verification and validation. There is no mention of clinical trials, human data, expert ground truth, or any form of AI performance evaluation.
Therefore, I cannot provide the detailed information requested regarding acceptance criteria, device performance from a clinical study, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC study results because this information is not present in the provided text.
The document primarily focuses on demonstrating equivalence through technical specifications and adherence to safety and performance standards for a light therapy device, not through clinical efficacy trials or AI performance evaluation.
§ 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.