(169 days)
The laser is intended to be used for cutting, and coagulating soft tissue.
The Fotona Skinlight system is based on Er: Y AG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in noncontact mode. The System is capable of emitting up to 1.0 Joule of pulsed light at 2.94 um, with a (nominal ) pulsewidth of 300 us. The Skinlight 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 flashlamp simmer current and main triggering pulse. b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger. c) An Er:YAG laser rod, capable of generating 1.0 Joule optical pulses at a frequency up to 15 Hz. d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece. e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
The provided text describes a medical device, the Fotona Skinlight system, and argues for its substantial equivalence to a predicate device (Schwartz Electro-Optics TriLase 2940). However, the text does not contain any information about acceptance criteria, device performance metrics, or any study that proves the device meets specific acceptance criteria.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details because this information is not present in the provided document.
The document discusses the laser's physical characteristics, intended use, and its technological similarities to a predicate device to argue for substantial equivalence, which is a regulatory pathway. It does not present clinical trial data or performance studies against predefined acceptance criteria.
{0}------------------------------------------------
Summary of Safety and Effectiveness Data Appendix F :
General Information and Description
1962902
The Fotona Skinlight system is based on Er: Y AG laser technology. Within the system, an optical cavity contains the Er: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece. The laser is used in noncontact mode.
The System is capable of emitting up to 1.0 Joule of pulsed light at 2.94 um, with a (nominal ) pulsewidth of 300 us. The laser is intended to be used for cutting, and coagulating soft tissue.
The Skinlight 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 flashlamp simmer current and main triggering pulse.
b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger.
c) An Er:YAG laser rod, capable of generating 1.0 Joule optical pulses at a frequency up to 15 Hz.
d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece.
e) The microprocessor based controller which regulates the functions of the laser and allows parameter selection by the user.
Summary of Substantial Equivalence
Fotona believes that its Skinlight system is substantially equivalent to the Schwartz Electro-Optics ( SEO ) TriLase 2940 ( K 953585 ).
The TriLase 2940 is cleared for the cutting, vaporization, and coagulation of soft tissue. It therefore has the same Intended Use as the Fotona Skinlight.
{1}------------------------------------------------
Technologically, the predicate has identical characteristics to Skinlight, both comprising a flashlamp pumped Er: Y AG laser rod generating light at a wavelength of 2.94 um, which is subsequently delivered to the patient via an articulated delivery arm and focusing handpiece.
Both devices have identical energy delivery capabilities and similar repetition rates.
It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.
Reference Literature Appendix G :
-
Anderson, RR "Selective Photothermolysis: precise microsurgery by selective absorption of pulsed radiation", Science 220, p 524-527.
-
Drnovsek, B "Clinical Applications of the Skinlight Er: Y AG laser", Dermatology and Aesthetic Surgery, vol 1.2.
-
Walsh, AJ, and Cummings, C, 'Dynamic Heating of water exposed to erbium laser pulses', 1994, Las.Surg.Med., 15(3), pp.295-305.
-
Kaufman, R., Hartmann, A, Hibst, R. 'Cutting and Skin-Ablative properties of pulsed mid-infrared laser surgery', 1994, J.Dermat.Surg.Oncol. 20, 112-118.
-
Kaufman, R., Hibst, R. 'Pulsed 2.94 um Er: Y AG laser skin ablation-experimental results and first clinical application', 1990,Clin.Exp.Derm., 15, 389-393.
-
Hibst, R.,Kaufman, R.'Effects of laser parameters on pulsed Er: YAG laser skin ablation', 1990, Las.Med.Sc., 6, 391-7.
§ 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.