K Number
K964074
Device Name
DIOLITE 532
Manufacturer
Date Cleared
1997-04-01

(172 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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.
More Information

No
The summary describes a laser system with specific technical parameters (wavelength, power, pulse duration, repetition rate, spot size) for photocoagulation. There is no mention of AI, ML, image processing, or any data-driven algorithms for analysis, diagnosis, or treatment planning. The description focuses solely on the physical characteristics and function of the laser delivery system.

Yes
The device is intended for "photocoagulation of vascular and pigmented skin lesions," which is a therapeutic intervention for medical conditions.

No
The device is intended for photocoagulation of vascular and pigmented skin lesions, which is a treatment, not a diagnostic process.

No

The device description explicitly states it is a "semiconductor-based laser system" and details hardware specifications like power, pulse duration, repetition rates, and spot size, indicating it is a physical device, not software only.

Based on the provided information, the DioLite™ 532 is not an IVD (In Vitro Diagnostic) device.

Here's why:

  • Intended Use: The intended use is for the "photocoagulation of vascular and pigmented skin lesions." This describes a therapeutic procedure performed directly on a patient's skin.
  • Device Description: The description details a laser system that delivers light for treatment. This is consistent with a therapeutic device, not a diagnostic one.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The DioLite™ 532 does not perform this function.

Therefore, the DioLite™ 532 is a therapeutic medical device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for 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.

Product codes

79 GEX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K954905, K951034, K883541, K903883

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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

K964074

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.

1

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.