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510(k) Data Aggregation
K Number
K103708Device Name
ML24000 UVA-1 PHOTOTHERAPY UNIT
Manufacturer
THE DAAVLIN DISTRIBUTING COMPANY
Date Cleared
2011-02-22
(64 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
THE DAAVLIN DISTRIBUTING COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
Device Description
The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with spectral output at peak wavelengths of 370-390 nm. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders. The desired dose is selected using the operator interface located on the front panel of the device. The ML24000 UVA-1 Phototherapy Unit delivers full body phototherapy, wherebv Philips CLEO HPA 1018 Medium Pressure Lamps, which surround the patient, deliver the specified dose of UVA-1.
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