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510(k) Data Aggregation
K Number
K061470Device Name
DEL SOL BLUE LIGHT THERAPY SYSTEM
Manufacturer
Date Cleared
2006-07-20
(55 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
EDGE SYSTEMS CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Del Sol Blue Light Therapy System is intended to provide photo therapeutic light to the body. The Del Sol Blue Light Therapy System is generally indicated to treat dermatological conditions. The Del Sol Blue Light Therapy System is specifically indicated to emit visible blue/violet light to treat moderate inflammatory acne vulgaris.
Device Description
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