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510(k) Data Aggregation
K Number
K041103Device Name
ACNELIFT
Manufacturer
INNER ACT, LLC
Date Cleared
2004-07-27
(91 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
INNER ACT, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AcneLift " is generally indicated for treatment of dermatological conditions and specifically indicated for the treatment of moderate inflammatory acne vulgaris.
Device Description
AcneLift uses panels of LED's which emit visible light of 407 ± 5 nm and is not associated with the risks or harmful side effects of ultraviolet radiation. Thermal Management is achieved by a fan mounted in close proximity to an aluminum heat sink. The lights are mounted to a mechanical arm and are controlled by an analog timing device. The treatment area is approximately 960 cm4 The total light emitted is 42 Watts giving a fluence of about 45 mW/cm2. Thus, AcneLift provides 50 Joules/cm of energy, in approximately 18-20 minutes.
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