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510(k) Data Aggregation
K Number
K060792Device Name
ILLUMIMED
Manufacturer
PHOTOACTIF, LLC
Date Cleared
2006-12-01
(253 days)
Product Code
ILY, GEX
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
PHOTOACTIF, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The illumiMed device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of 430 ±10 nm "blue" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of the 660 ±10 nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs are indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the accessory "38 blue LED Wand", 430 ±10 nm "blue", is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Use of the accessory "38 red/near infrared LED Wand", 660 ± 10nm "red" LEDs and of the 940 ±10 nm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature: for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the accessory "240 red/near infrared LED Pad", 660 ± 10nm "red" LEDs and of the 940 ±10 mm "near infrared" LEDs, is indicated for delivery of heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase blood circulation.
Use of the combination of 430 nm "blue" LEDs, 660 nm "red" LEDs and of the 940 nm "near infrared" LEDs is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Device Description
The submitted device, illumiMed, is a treatment method using specific wavclengths of polychromatic energy produced by super-luminous LEDs (light emitting diodes) to treat a variety of skin and body conditions. It is an affordable, pain-free means to address a variety of dermatological concerns. The IR spectrum is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promotion the relaxation of muscle tissue; and to temporarily increase local blood circulation. The blue spectrum is intended to reduce mild to moderate acne vulgaris. Use of the combination of blue, red and near infrared regions of the spectrum is intended to emit energy to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
The control panel displays to the operator what treatment is being performed and provides the user with a choice of using the LED panels on the arm, LED attachments or both for any chosen treatment protocol.
The software component of the device controls an appropriate number of treatment protocols and each protocol can be enabled by a single action push-pad or button on the control panel. The software can be upgraded by the manufacturer.
The illumiMed device is powered by grounded 120 volt electrical power with an operator controlled on/off switch. The device is housed in a unit that is mounted on four wheels allowing it to be moved to any location desired by the operator.
The control panel has push-pads or buttons that control its operation and software functionality. The software functionally can be upgraded by the manufacturer. The device has a panel arm extension that can hold between one (1) and five (5) LED panels and can be cantilevered in any direction for LED treatment of a patient in a prone, seated or standing position. The LED panels can be combinations of LEDs at 7660 nm ("red"), y 940-950 nm (near infrared), and (430 nm ("blue"). The panels can be configured as an individual panel or in combinations up to five panels of LEDs. Accessory LED pads and wands are available for additional treatment modalities with 660 nm, 940 nm and 430 nm LED diodes.
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