(172 days)
The DioLite™ 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.
The DioLite 532 is a semiconductor-based dermatology laser system which delivers 532 nm laser light. The system delivers up to 3 Watts of power, in pulses of 1 to 100 milliseconds duration, at repetition rates up to 15 Hz, into treatment spots of 200 to 1400 microns diameter.
This 510(k) summary for the IRIDEX Corporation DioLite™ 532 does not contain information regarding objective acceptance criteria or a study designed to prove the device meets such criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and intended use. It describes the device's technical specifications and compares them to other legally marketed laser devices.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, or ground truth details for an acceptance criteria study. This information is not present in the provided text.
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APR - 1 1997
510(k) Summary IRIDEX Corporation DioLite™ 532
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Bradley J. Renton, Ph.D. IRIDEX Corporation 340 Pioneer Way Mountain View, CA 94041 415-962-8100
Contact Person: (same as above)
Date Prepared: October 10, 1996
Name of Device and Name/Address of Sponsor
DioLite™ 532
IRIDEX Corporation 340 Pioneer Way Mountain View, CA 94041
Classification Name
Laser Instrument, Surgical, Powered CFR Section: 878.4810 Product Code: 79 GEX
Predicate Devices
The DioLite 532 Laser System is substantially equivalent to other currently legally marketed laser devices including the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System (K883541, K903883).
Intended Use
The DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light intended to be used for the photocoagulation of vascular and pigmented skin lesions.
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Technological Characteristics and Substantial Equivalence
The DioLite 532 is a semiconductor-based laser system which delivers 532 nm laser light. The DioLite 532 uses infrared (808 nm) semiconductor diode laser light as the primary source of energy which is then wavelength converted to visible green 532 nm laser light for delivery to the patient and treatment. A second visible red (630-650 nm) semiconductor diode laser is used for aiming.
The DioLite 532 is substantially equivalent to other currently legally marketed dermatology laser devices including the Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905), the Laserscope, Aura Laser System (K951034), and the Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System (K883541, K903883). All of these predicate devices are indicated to be used for the photocoagulation of vascular and pigmented skin lesions.
The Continuum Biomedical, Inc., CB Diode/532 Laser System uses infrared (808 nm) semiconductor diode laser light as the primary source of energy which is then wavelength converted to visible green 532 nm laser light for delivery to the patient and treatment. The CB Diode/532 Laser System delivers the same wavelength, equivalent average power, pulses of equivalent duration, and treatment spots of equivalent diameter to the DioLite 532.
The Laserscope, Aura Laser System uses arc lamps as the primary energy source to optically pump a Nd: YAG laser rod, the output of which is wavelength converted to visible green 532 nm laser light for delivery to the patient and treatment. The Aura Laser System delivers the same wavelength, similar average power, pulses of equivalent duration, and treatment spots of equivalent diameter to the DioLite 532.
The Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System uses electrical energy to excite a metal vapor discharge to produce yellow 578 nm and green 511 nm laser light for delivery to the patient and treatment. The Vasculase Copper Vapor Laser System delivers similar wavelengths, similar average power, pulses of similar duration, and treatment spots of similar diameter to the DioLite 532.
Device Description
The DioLite 532 is a semiconductor-based dermatology laser system which delivers 532 nm laser light. The system delivers up to 3 Watts of power, in pulses of 1 to 100 milliseconds duration, at repetition rates up to 15 Hz, into treatment spots of 200 to 1400 microns diameter.
§ 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.