(27 days)
The ProLite / Plasmalite MPX Pulsed Light System is indicated for use to remove unwanted hair in all skin types according to the Fitzpatrick Scale.
The ProLite / Plasmalite MPX Pulsed Light System delivers pulsed light at a wavelength beginning at a wavelength of 600 nm. The device consists of three interconnected sections: The cabinet which houses the internal cooling system, power supply and microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
The provided text does not contain any information regarding acceptance criteria or a study proving device performance.
The document is a 510(k) summary for the ProLite / Plasmalite MPX Pulsed Light System. It states that "Performance Data: None" and concludes that the device is "substantially equivalent to other existing pulsed light systems in commercial distribution for removal of unwanted hair in all skin types according to the Fitzpatrick Scale."
Therefore, I cannot provide the requested information.
§ 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.