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510(k) Data Aggregation
K Number
K103540Device Name
PSORIA-LIGHT
Manufacturer
PSORIA-SHIELD INC.
Date Cleared
2011-02-10
(70 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
PSORIA-SHIELD INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Psoria-Light Model PS1000 is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
Device Description
Psoria-Light™ Model PS1000 delivers targeted ultraviolet (UV) light to small regions of affected skin (2.88 cm), sparring healthy skin. The system is capable of delivering either UVB light (300 to 320nm) or UVA light (350 to 395nm). Psoria-Light™ Model PS1000 generates both UVA and UVB light via LED technology, avoiding environmental concerns associated with disposal and exchange of mercury gas lamps, Xenon, and Chlorine gases commonly associated with targeted UV phototherapy devices. Psoria-Light's™ UVB LEDs emit light between 300 and 320 nm, avoiding light emissions below 300nm. Psoria-Light™ Model PS1000 incorporates a unique safety feature, a non-contact sensor located about the aperture of the handpiece that detects human skin. The trigger mechanism for UV dosage administration (located on the handpiece) is disabled until a suitable surface is detected by this sensor.
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