DIOLITE 532

K964074 · Iriderm Div. · GEX · Apr 1, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K964074
• Device Name: DIOLITE 532
• Applicant: Iriderm Div.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Semiconductor-based laser system; delivers 532 nm green laser light for photocoagulation of vascular and pigmented skin lesions. Primary energy source: 808 nm infrared diode laser, wavelength-converted to 532 nm. Includes 630-650 nm red diode aiming beam. Operated by clinicians in dermatology settings. System delivers up to 3 Watts power, 1-100 ms pulse duration, up to 15 Hz repetition rate, and 200-1400 micron spot sizes. Output used by physician to target skin lesions; thermal energy induces photocoagulation. Benefits include precise treatment of vascular/pigmented lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semiconductor-based laser system. Primary energy: 808 nm infrared diode laser; wavelength-converted to 532 nm visible green light. Aiming beam: 630-650 nm red diode laser. Output: up to 3 Watts, 1-100 ms pulse duration, up to 15 Hz, 200-1400 micron spot diameter. Standalone device.

Indications for Use

Indicated for photocoagulation of vascular and pigmented skin lesions in dermatology patients.

Regulatory Classification

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.

Predicate Devices

• Continuum Biomedical, Inc., CB Diode/532 Laser System (K954905)
• Laserscope, Aura Laser System (K951034)
• Innovative Health Concepts, Inc., Vasculase Copper Vapor Laser System (K883541, K903883)

Submission Summary (Full Text)

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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.

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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.