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510(k) Data Aggregation
K Number
K061589Device Name
SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
Manufacturer
Date Cleared
2006-08-04
(57 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
Device Description
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K Number
K031800Device Name
SOLARC/SOLRX 500 SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY A NEW MEDICAL DEVICE FAMILY CONSISTING OF 5 MODELS:
Manufacturer
Date Cleared
2003-09-10
(91 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 500 Series is an ultraviolet phototherapy lamp unit used for the physician prescribed treatment of psoriasis, vitiligo, atopic dermatitis (eczema). It is intended for use as a spot treatment device, or as a hand & foot device. It is intended for use on all skin types. (I-VI)
Device Description
A new medical device family consisting of 5 models: 510UVB-NB, 520UVB-NB, 530UVB-NB, 540UVB-NB, 550UVB-NB. The proposed device uses low pressure mercury vapor fluorescent ultraviolet bulbs. It has a digital timer, a keyed switchlock, wire bulb guards, FDA compliant ultraviolet protective goggles, and a removable hood.
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