(504 days)
The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.
The Clear Wave® Phototherapy System for Acne is a hand held light device which emits a low intensity of blue light at a wavelength of 414 ± 10 nm in the visible range of the spectrum. The head is programmed with a timed treatment cycle. The light modules are contained in the changeable head of a hand held device. The Clear Wave® Phototherapy System for Acne is small and light weight which allows for easy handling and mobility.
This looks like a 510(k) submission for a phototherapy device for acne, not an AI/ML medical device. The provided text describes the device, its intended use, and substantial equivalence to a predicate device, focusing on electrical safety, biocompatibility, and usability testing. There is no mention of an algorithm or AI.
Therefore, most of the requested information regarding acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies is not applicable to this document.
§ 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.