(90 days)
Blue (415-425mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (630-640nm) and Infrared (820-830mm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible 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 stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Photo-Therapy Device SMARTLUX MINI is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).
The device produces light in the following regions of the light spectrum:
- · Red (630-640nm)
- · Blue (415-425nm)
- · Yellow (585-595nm)
- Infra-red (820-830nm)
This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.
The provided text is a 510(k) summary for the Smartlux Mini device, which is a phototherapy unit. It details the device's characteristics and its substantial equivalence to a predicate device (Soli-Lite LG4 Galileo). However, it does not contain information about clinical studies with acceptance criteria or performance metrics related to diagnostic accuracy, sensitivity, specificity, or reader studies.
The document primarily focuses on:
- Non-Clinical Testing: Conformance to electrical safety, electromagnetic compatibility, and performance standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471).
- Software Validation: The software was designed, developed, verified, and validated according to a software development process, and is considered a "MODERATE level of concern software."
- Technological Equivalence: Comparison of wavelengths, irradiance, and operation modes to a predicate device (K192755).
Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical efficacy or diagnostic performance, nor can I answer questions about sample sizes for test/training sets, expert ground truth establishment, adjudication methods, or MRMC studies, as this information is not present in the provided document.
The document states that "Testing of key performance characteristics demonstrates that the subject device can be used safely and effectively for the proposed indications for use," but it does not elaborate on what these "key performance characteristics" are in terms of clinical outcomes or how effectiveness was quantitatively demonstrated by such testing, beyond the non-clinical testing listed.
§ 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.