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The Fotona Skinscan system is a microprocessor controlled device which generates precisely defined patterns on skin tissue in an automated sequence to increase uniformity and ease of treatment when used in conjunction with a host Skinlight system. The Fotona Skinscan system is designed as an accessory for use with the Fotona Skinlight laser system. Skinscan is functionally integrated to the host laser system. When the scanner head is attached to the articulated arm and the scanner cable is connected, the host laser system recognizes the presence and activation of the accessory and permits activation of the scanner specific modes which are programmed into the host at time of installation of the scanner accessory. In these modes scanner settings can be selected from an easy-toread menu. When the operator reverts to use of the standard dermatological handpiece, these settings are not accessible. When the scanner is connected and a scanner sub-menu is selected the system automatically initiates for scanner operation. The Skinscan system is designed with 3 major sub-systems a) A scanner handpiece comprising smoke evacuation components and distance gauge components. b) A scanner head, containing scanning mirrors and imaging optics. c) An electronic control hox containing scanning mirror control and laser interface circuitry.
The provided text describes a medical device called the Fotona Skinscan system, an accessory for the Fotona Skinlight laser system. However, the text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or information about MRMC studies, standalone performance, or training set specifics based on the provided input.
The text focuses solely on:
- Description of the device: Its components, function as an accessory to the Skinlight laser, and how it integrates with the host system.
- Claim of substantial equivalence: Comparing it to the Coherent CPG system and stating that it raises no new questions of safety or effectiveness.
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Summary of Safety and Effectiveness Data Appendix E .
General Information and Description
The Fotona Skinscan system is a microprocessor controlled device which generates precisely defined patterns on skin tissue in an automated sequence to increase uniformity and ease of treatment when used in conjunction with a host Skinlight system.
The Fotona Skinscan system is designed as an accessory for use with the Fotona Skinlight laser system. Skinscan is functionally integrated to the host laser system. When the scanner head is attached to the articulated arm and the scanner cable is connected, the host laser system recognizes the presence and activation of the accessory and permits activation of the scanner specific modes which are programmed into the host at time of installation of the scanner accessory. In these modes scanner settings can be selected from an easy-toread menu. When the operator reverts to use of the standard dermatological handpiece, these settings are not accessible. When the scanner is connected and a scanner sub-menu is selected the system automatically initiates for scanner operation.
The Skinscan system is designed with 3 major sub-systems
a) A scanner handpiece comprising smoke evacuation components and distance gauge components.
b) A scanner head, containing scanning mirrors and imaging optics.
c) An electronic control hox containing scanning mirror control and laser interface circuitry.
No accessories are available for use with Skinscan
Summary of Substantial Equivalence
Fotona believes that its Skinscan system is substantially equivalent to the Coherent CPG system, previously cleared under K 946304.
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Premarket notification : Fotona Skinlight Laser
Technologically, the predicate has identical characteristics to Skinscan, both comprising an 2 cetaronic control module, a scanner head and a scanner handpiece.
Both devices act as accessories to host laser systems and are not themselves active components.
It is therefore believed that there are no new questions of Safety or Effectiveness raised by the introduction of this device.
§ 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.