(156 days)
Treatment of cutaneous vascular and pigmented lesions.
The CB Diode/532 consists of the laser enclosure and the fiber optic delivery system. The laser enclosure contains the DC Power supply, switching electronics, the laser bench and the Control Panel. The laser bench contains a NdYAG rod pumped by two stacks of diodes rather than the customary flash lamps. The use of diodes to excite the NdYAG rod is a major advance in technology. It increases the over all efficiency of the system while reducing the size and weight of the package. The diodes are also designed for long lifetime thereby reducing the operating costs substantially. In all laser systems operating cw or quasi-cw, a gated pulse is produced by opening and closing a shutter. The shutter is opened for the operator selected exposure time. The use of diodes to pump the NdYAG laser eliminates the need for the mechanical shutter to control the pulse duration. The diodes are switched on and off by an electrical pulse. Lasing occurs only when the diodes are energized. Control of the exposure time is very accurate and not subject to degradation as a mechanical device is. This feature increases both the reliability and safety of the equipment. The fiber optic delivery system is designed for 400μ, 800μ, and 1200u fibers. The fiber optic delivery system connects to the laser using a standard SMA connector. The delivery of the laser light from the output of the fiber is controlled by a hand piece, which serves as the aperture. The Control Panel is an integral part of the laser housing. It connects to a microprocessor which is the brains of the system. The microprocessor monitors all interlocks for safety and set the various parameters selected by the user. The laser weighs less than 100 pounds, is easily portable. It generally sits on a counter top. It operates on 110 volt power.
This document is a 510(k) summary for a medical device (laser system) from 1996. It explicitly states:
- Nonclinical Performance Data: none
- Clinical Performance Data: none
Therefore, based on the provided text, there is no information available about acceptance criteria or a study that proves the device meets acceptance criteria. The submission relies on substantial equivalence to previously cleared devices.
As such, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details, because this data is not present in the provided document.
{0}------------------------------------------------
K 95$\overline{4905}$
510(k) Summary
MAR 2 9 1996
Submitter: Continuum Biomedical, Inc. 547 Rhea Way Livermore, CA 94550 Phone: 510-606-6118 Fax: 510-447-8378 Contact: Robert S. Anderson, Ph. D. President Date Summary Prepared: October 24, 1995 Device Trade Name: CB Diode/532 Laser System Common Name: Dermatology laser system Classification Name: Instrument, surgical, powered, laser 79-GEX 21 CFR 878.48 Equivalent Device: LaserScope Aura Laser System (K951034) LaserScope SL Series 12 Watt KTP (K933880) Device Description: The CB Diode/532 consists of the laser enclosure and the fiber optic delivery system. The laser enclosure contains the DC Power supply, switching electronics, the laser bench and the Control Panel. The laser bench contains a NdYAG rod pumped by two stacks of diodes rather than the customary flash lamps. The use of diodes to excite the NdYAG rod is a major advance in technology. It increases the over all efficiency of the system while reducing the size and weight of the package. The diodes are also designed for long lifetime thereby reducing the operating
costs substantially.
{1}------------------------------------------------
510(k) Summary (cont'd)
Device Description: (cont'd)
In all laser systems operating cw or quasi-cw, a gated pulse is produced by opening and closing a shutter. The shutter is opened for the operator selected exposure time. The use of diodes to pump the NdYAG laser eliminates the need for the mechanical shutter to control the pulse duration. The diodes are switched on and off by an electrical pulse. Lasing occurs only when the diodes are energized. Control of the exposure time is very accurate and not subject to degradation as a mechanical device is. This feature increases both the reliability and safety of the equipment.
The fiber optic delivery system is designed for 400μ, 800μ, and 1200u fibers. The fiber optic delivery system connects to the laser using a standard SMA connector. The delivery of the laser light from the output of the fiber is controlled by a hand piece, which serves as the aperture.
The Control Panel is an integral part of the laser housing. It connects to a microprocessor which is the brains of the system. The microprocessor monitors all interlocks for safety and set the various parameters selected by the user.
The laser weighs less than 100 pounds, is easily portable. It generally sits on a counter top. It operates on 110 volt power.
Treatment of cutaneous vascular and pigmented lesions.
Both the LaserScope Aura Laser System and the LaserScope "SL Series Lasers" 12 Watt KTP Laser System emit light at 532nm in a gated pulse mode. Indications for use, target, chromophore, delivery system, spot size, mode of operation, exposure duration, average laser power, energy to lesion aiming beam, laser wavelength, etc. for the ConBio CB Diode/532 Laser System are all within the parameters currently in use by other systems which have been previously found to be substantially equivalent.
Intended Use:
Comparison:
{2}------------------------------------------------
· 510(k) Summary (cont'd)
Nonclinical Performance Data: none
Clinical Performance Data: none
Conclusion:
The CB Diode/532 Laser System is substantially equivalent to existing surgical laser systems in commercial other distribution for the treatment of cutaneous vascular and pigmented lesions.
Additional Information:
None requested at this time.
§ 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.