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510(k) Data Aggregation
K Number
K073659Device Name
XTRAC ULTRA 2, MODEL AL10000
Manufacturer
PHOTO MEDEX, INC.
Date Cleared
2008-03-05
(70 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTO MEDEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
Device Description
The XTRAC Ultra Excimer Laser System, Model AL10000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic wavelength of 308 nm. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.
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K Number
K051428Device Name
VTRAC EXCIMER LAMP SYSTEM
Manufacturer
PHOTO MEDEX, INC.
Date Cleared
2005-08-09
(69 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTO MEDEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UVB phototherapy for skin conditions which include psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Device Description
The VTRAC Excimer Lamp System is a self-contained non-invasive (non-ablating) system that emits targeted (ultra-narrow) ultraviolet wavelength that is included in the UV-B region of the electromagnetic spectrum centered at 308 mm, which is effective for the treatment of skin conditions that respond favorably to and available UV-B phototherapy. UV-B is emitted from a XeCl excimer lamp inside a handpiece used to apply targeted UVB energy to only areas that require treatment, thus allowing non-involved areas (healthy) of the skin to be spared from exposure.
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K Number
K041943Device Name
XTRAC XL, MODEL AL8000
Manufacturer
PHOTO MEDEX, INC.
Date Cleared
2004-10-14
(87 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTO MEDEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
Device Description
The XTRAC XL2 Excimer Laser System Model AL8000 is a complete self-contained compact UVB laser light source, which utilizes a XeCl gas mixture to generate an operator selected dose and target-specific ultraviolet light at monochromatic operater services ann. The laser system consists of a touch-screen display, an advanced fiberoptic cable attached to a handpiece, and a foot-switch to initiate exposure. The laser is enclosed in a protective interlocked housing. The unit is designed to operate on standard AC power available from wall outlets and can accommodate US, European and other nominal supply voltages and operating frequencies.
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K Number
K031451Device Name
XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000
Manufacturer
PHOTO MEDEX, INC.
Date Cleared
2003-08-01
(86 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTO MEDEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
Device Description
The XTRAC XL Plus Excimer Laser Phototherapy Svstem is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate dose-selected and target specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a foot-switch. The laser is enclosed in a protective interlocked housing.
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K Number
K020847Device Name
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
Manufacturer
PHOTO MEDEX, INC.
Date Cleared
2002-05-16
(62 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTO MEDEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UVB Phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma
Device Description
The XTRAC Excimer Laser System is a complete self-contained compact UV laser light source, which utilizes a XeCl gas mixture to generate an operator selected doseand target-specific ultraviolet light at wavelength of 308 nm. The laser system consists of a keypad and display, a fiberoptic delivery system, a handpiece and a footswitch. The laser is enclosed in a protective interlocked housing.
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K Number
K011382Device Name
XTRAC EXCIMER LASER SYSTEM, MODEL AL 7000
Manufacturer
PHOTO MEDEX, INC.
Date Cleared
2001-08-02
(87 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTO MEDEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K003705Device Name
XTRAC EXCIMER LASER SYSTEM, MODEL AL7000
Manufacturer
PHOTO MEDEX, INC.
Date Cleared
2001-03-01
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
PHOTO MEDEX, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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