(90 days)
The Forona Novalis R Ruby Laser System for removal of unwanted body hair.
The Fotona Novalis R system is based on Ruby laser technology. Within the system, an optical cavity contains the Ruby crystal, which is activated by means of the use of flashlamps. Pulsed laser cacrev is provided through an optical fiber beam delivery system. While observing and directing, the aiming beam (diode laser, 635 nm), the treatment beam is administrated by the physician through a footwitch. The laser is used in non-contact mode.
The System is capable of emitting up to 25 J of pulsed light at 694 nm This light has a pulsewidth which varies in the range from I to 4 ms and can be adjusted by the user. The spot sizes from 8 to 14 mm can be chosen on the handpiece and are detected by the microprocessor controller. The corresponding energy fluence to tissue is displayed on a screen. The maximum fluence of 503/cm² can be achieved by selecting the highest out energy and the smallest spot size.
The Novalis R system is designed with 5 major sub-systems:
a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the tlashlamp simmer current and main triggering mille
b) A cooling system consisting of an internal water flow circuit together with warer-to-air heat exchanger.
c) An ruby laser rod, capable of generating 25 J optical pulses at a frequency up to 2 Hz.
d) An optical delivery system, interfacing the encrgy from the lascr to the patient via an optical fiber and a handpiccc.
a) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
The provided text is a 510(k) summary for the Fotona Novalis R Ruby Laser System, seeking clearance for marketing based on substantial equivalence to predicate devices. It describes the device's technology and intended use. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement in a typical medical device performance study.
Therefore, I cannot fulfill your request for this specific document. The information you are asking for (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is characteristic of a clinical performance study or validation study which is not present in this summary.
This document focuses on demonstrating substantial equivalence to already cleared devices, rather than presenting a de novo performance study with specific acceptance criteria and detailed outcomes. It states that "no new questions of Safety or Effectiveness raised by the introduction of this device."
To reiterate, the requested information (acceptance criteria and detailed study data) is not available in the provided text.
§ 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.