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510(k) Data Aggregation
K Number
K103204Device Name
SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
Manufacturer
Date Cleared
2011-04-27
(177 days)
Product Code
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
SOLARC SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Solarc/SolRx E-Series Ultraviolet Phototherapy Lamp Family is a wall-mounted or self-supporting ultraviolet phototherapy lamp unit used for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). It is intended for use as a spot or full-body treatment device. It is intended for use on all skin types. (I -VI)
This device is intended for Prescriptive Use only, per Part 21 CFR 801 Subpart D.
Device Description
A new family of medical devices that can be used singly, or ganged together in any number and combination of models. The devices use various numbers and lengths of tubular ultraviolet fluorescent bulbs. The model numbering system for single devices is as follows: Ehn0t-waveband-suffix. The proposed device is constructed primarily of sheet metal, and has provision for connecting additional lighting banks. The proposed device can be made in 2-foot, 4-foot and 2-metre lengths. The proposed device has provision for ultraviolet reflective side panel doors. The treatment area of the proposed device can be reduced by using the "Face Shield" accessory. The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. The proposed device uses 2 to 12 bulbs per device, or multiples thereof when devices are ganged together. The proposed device uses a digital countdown timer. The proposed device has a keyed switchlock or timer password entry to prevent unauthorized usage, wire guards or an acrylic window to reduce the chance of bulb breakage, and FDA compliant ultraviolet protective goggles.
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