(67 days)
K 946304
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No
The description focuses on microprocessor control and automated sequences for generating patterns, which are standard features of automated medical devices and do not inherently indicate AI/ML. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No
The device is an accessory to a laser system and is described as generating patterns on skin tissue for treatment, but it does not directly perform therapeutic action itself.
No
The device description states that the Fotona Skinscan system generates patterns on skin tissue for treatment purposes, and it is an accessory for a laser system. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description explicitly details hardware components such as a scanner handpiece, scanner head with mirrors and optics, and an electronic control box. It is described as a microprocessor-controlled device that generates patterns on skin tissue, indicating a physical interaction with the patient.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a device that interacts directly with skin tissue using a laser. There is no indication of testing biological samples (like blood, urine, or tissue) outside of the body.
- Direct interaction with the body: The device is described as generating patterns on "skin tissue," which is a direct interaction with the human body, not an in vitro process.
- Accessory for a laser system: It's an accessory for a "Skinlight laser system," which is typically used for dermatological treatments performed directly on the skin.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function as described does not align with the definition of an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device 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-to read 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K 946304
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 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.
1
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.