(123 days)
The "CHERYLAS-15N and CHERYLAS-20N" are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source.The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1470mm. It features impact structure, high efficiency and long lifetime. Generally the beam shall be shamed as the big beam divergence of the laser from the diode. When the coaxiality of laser and fiber meet the requirements, the laser beam can be coupled efficiently into the fiber.
The block diagram shows how the diode laser system works. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system, it supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system. The system can test and calibrate power by the calibration and feedback unit.
The provided document is a 510(k) premarket notification for a medical device (Medical Diode Laser Systems) and primarily focuses on proving substantial equivalence to a predicate device based on technical characteristics and adherence to safety standards. It explicitly states "Clinical data: Not applicable." Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or the improvement of human readers with AI assistance.
The information provided pertains to the device's technical specifications, intended use, and comparison to a predicate device, focusing on safety and technological equivalence rather than AI/algorithm performance.
To answer your request, the document would need to include details about a clinical study or a robust non-clinical performance study with specific metrics, a test set, ground truth establishment, and statistical analysis, which is absent.
§ 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.