(99 days)
Indications for use for ELYSION diode laser hair removal system with 755nm and 810nm applicators include: · Hair Removal with Static and Dynamic modes intended for permanent reduction in hair regrowth, defmed as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime. · Treatment of Pseudofolliculitis barbae (PFB) · Use on all skin types (Fitzpatrick I-VI).
ELYSION diode laser hair removal system is a medical electrical equipment intended for hair removal treatment, the basic principle of which is selective photothermolysis, which consist in the specific destruction of a follicle due to an increase of the temperature induced by a high-powered beam of light which is selectively absorbed by the melanin. The ELYSION equipment consists of a central unit and a set of 3 removable applicators. The ELYSION equipment emits laser radiation (near-infrared light with a wavelength range of 755 nm & 810 nm), pulsed through the laser aperture situated at the tip of the applicator. The device applicator contains the diode which emits the laser energy whereas the power delivered, and the working frequency being controlled by the machine's central unit. The applicator emits the energy through a sapphire window, in contact with the skin throughout the treatment, aimed at damaging the hair follicle. The device has three types of applicators differentiated by the emitted wavelength and the area of emission. Two of the applicators emitting radiation at 810 nm wavelength for two areas 10×10 mm² and 18×10 mm² and another one emitting radiation at 755 nm for an area of 10×10 mm². Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-2-3 Hz for static and 5-10-15 Hz for dynamic). The emission of energy is activated in the form of continuous pulses when pressing the applicator button. The applicator sapphire tip is cooled to a constant temperature to cool the skin, so that it partially anaesthetizes the tissue reducing the risk of damage to the epidermis during treatment.
The provided document is a 510(k) summary for the ELYSION diode laser hair removal system. It describes the device, its indications for use, and a comparison to legally marketed equivalent devices to demonstrate substantial equivalence.
However, it explicitly states:
"No clinical study is included in this submission"
Therefore, the document does not contain the information required to answer your questions about acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. The approval for this device appears to be based on non-clinical testing and substantial equivalence to predicate devices, rather than a clinical study demonstrating specific performance metrics against pre-defined 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.