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510(k) Data Aggregation
K Number
K051681Device Name
DERMILLUME RED, MODEL HR1000
Manufacturer
CARE ELECTRONICS, INC.
Date Cleared
2005-07-27
(34 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
CARE ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarity increase local blood circulation.
Device Description
The Dermillume Red HR1000 lamp is a compact light source that delivers high intensity narrow band red and near infrared light to the skin surface. The light sources are narrow bandwidth LEDs mounted in an array to give even and safe illumination of skin surfaces. The principal parts of the lamp are a light unit, positioning arm and firmware timer to control duration of exposure.
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K Number
K043575Device Name
DERMILLUME, MODEL PRO1000
Manufacturer
CARE ELECTRONICS, INC.
Date Cleared
2005-02-24
(59 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
CARE ELECTRONICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
Device Description
The Dermillume Pro1000 device is a compact light source that delivers high intensity narrow band blue and red light to the body for the treatment of acne vulgaris. The light sources are narrow wavelength LEDs that supply a spectral output of 414 ± 5 nm (blue) and 633 ± 5 nm (red). The device supplies 20 and 10 mW/cm² for blue and red light, respectively, at 4.6 inches distance from the skin surface. The principal parts of the device are a light unit, positioning arm and firmware timer to control duration of exposure. Additional off-the-shelf electronic devices related to treatment data acquisition and storage may be supplied as user options.
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