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510(k) Data Aggregation
K Number
K091568Device Name
LH-75 PHOTOTHERAPY SYSTEM
Manufacturer
LERNER MEDICAL DEVICES, INC.
Date Cleared
2009-11-05
(156 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
LERNER MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LH-75 Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75 Phototherapy System is intended for use on all skin types (I -VI).
Device Description
Not Found
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K Number
K090097Device Name
LH-75T PHOTOTHERAPY SYSTEM
Manufacturer
LERNER MEDICAL DEVICES, INC.
Date Cleared
2009-02-26
(42 days)
Product Code
FTC, CLA
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
LERNER MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LH-75T Phototherapy System is intended for use, by or under the direction of a physician, in UVB phototherapy for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The LH-75T Phototherapy System is intended for use on all skin types (I -VI).
Device Description
The LH-75T Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 mm) light for use in phototherapy and allows delivery of controlled doses!
The LH-75T consists of a Console that contains the electronics and a Handpiece that contains the lamp and the ballast. The console and handpiece are connected with an electrical cable. A Spot Treatment Attachment (LP-3) jand a Fiber-optic Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Brush Attachment (LB-10) are connected to the handpiece for selective treatment of skin lesions without exposure of adjacent, healthy tissues. The desired dose is selected using controls on the panel of the console and activated with either a switch on the panel or foot-switch. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
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K Number
K040062Device Name
LEVIA PHOTOTHERAPY SYSTEM
Manufacturer
LERNER MEDICAL DEVICES, INC.
Date Cleared
2004-02-13
(31 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
LERNER MEDICAL DEVICES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Levia Phototherapy System is intended for use in UVB phototherapy for the treatment of psoriasis including scalp psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leucoderma.
The Levia Phototherapy System is intended for use on all skin types (I -VI).
Device Description
The Levia Phototherapy System is an ultraviolet Light Source and energy delivery system. The System emits UV-B (290-320 nm) light for use in phototherapy and allows delivery of controlled doses. The desired dose is selected using controls on the panel of the Light Source and activated with a switch on the panel or remotely by a foot switch. A Spot Handpiece and a Fiber-optic Brush allow for selective treatment of skin lesions without exposure to neighboring, healthy tissues. The Spot Handpiece and Fiber-optic Brush connect to Light Source with a flexible Light Guide. The system is powered by a common household AC outlet. Protective eyewear is supplied with the system.
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