(169 days)
K 953585
No
The description focuses on the hardware components and a microprocessor-based controller for regulating functions and parameter selection, with no mention of AI or ML capabilities.
Yes
The "Intended Use / Indications for Use" section states that the laser is intended for "cutting, and coagulating soft tissue," which are therapeutic actions. The "Device Description" also mentions "therapeutic and aiming beams are guided down an articulated arm delivery system to a focusing handpiece," further confirming its therapeutic purpose.
No
The device description and intended use clearly state that the laser is for "cutting, and coagulating soft tissue," which are therapeutic actions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly outlines multiple hardware components including a laser rod, power supply, cooling system, and optical delivery system, in addition to a microprocessor-based controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting, and coagulating soft tissue." This describes a therapeutic or surgical application performed directly on a patient's body.
- Device Description: The description details a laser system designed to deliver energy to tissue. This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions.
Therefore, the Fotona Skinlight system, as described, is a therapeutic laser device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The laser is intended to be used for cutting, and coagulating soft tissue.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K 953585
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 :
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Anderson, RR "Selective Photothermolysis: precise microsurgery by selective absorption of pulsed radiation", Science 220, p 524-527.
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Drnovsek, B "Clinical Applications of the Skinlight Er: Y AG laser", Dermatology and Aesthetic Surgery, vol 1.2.
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Walsh, AJ, and Cummings, C, 'Dynamic Heating of water exposed to erbium laser pulses', 1994, Las.Surg.Med., 15(3), pp.295-305.
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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.
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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.
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Hibst, R.,Kaufman, R.'Effects of laser parameters on pulsed Er: YAG laser skin ablation', 1990, Las.Med.Sc., 6, 391-7.