(77 days)
Phototherapy Systems use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.
The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris
The red light (630mm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions
The infrared light (835nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, atthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
The Phototherapy Systems HS-770 is a vertical device which uses specific wavelengths of light, produced by LEDs (Light emitting diodes), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (630±15nm), in the blue light regions of the light spectrum (415±15nm) and infrared light region of light spectrum (835±15nm). Three or four sets of LEDs panels are available for the device.
The provided text is a 510(k) Summary for a Phototherapy System, which details its specifications and compares it to a predicate device. It explicitly states that clinical testing was not applicable or performed for this submission to establish substantial equivalence.
Therefore, the document does not contain any information regarding acceptance criteria studies, device performance metrics against such criteria, sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or details about training sets.
The information provided only covers non-clinical testing for electrical safety and electromagnetic compatibility to demonstrate compliance with recognized standards.
Based on the provided text, I cannot answer the questions about acceptance criteria and the study that proves the device meets them because the document states "Clinical Testing: It is not applicable."
§ 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.