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510(k) Data Aggregation
K Number
K212771Device Name
LightStim Elipsa
Manufacturer
LED Intellectual Properties LLC
Date Cleared
2022-01-26
(148 days)
Product Code
OHS, OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LED Intellectual Properties LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LightStim Elipsa is a LED light therapy device which uses specific wavelengths of light emitting diodes (LEDs). It is intended to emit energy in the red and infrared region of the light spectrum to provide treatment for full face wrinkles. The blue and red light spectrum is intentent of mild to moderate inflammatory acne.
Device Description
The LightStim Elipsa is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device uses four types of LEDs for Wrinkles: 612nm amber, 645nm red, 655nm red, and 850nm infrared and two types of LEDs for Acne: 410nm and 645nm. The treatment time is controlled by the user. There are no user settings or adjustments required. The LightStim Elipsa system components include the device containing the LED module, power supply, goggles, and travel case. The LightStim Elipsa does not contain any user serviceable components. The device is sold as Over-the-counter (OTC)
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K Number
K153399Device Name
LightStim Professional LED Bed
Manufacturer
LED Intellectual Properties LLC
Date Cleared
2016-07-05
(224 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LED Intellectual Properties LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LightStim Professional LED Bed is an over-the-counter device intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
Device Description
The LightStim Professional LED Bed is a device that is similar in design to the bottom half of a tanning bed. It is approximately 6.5 feet in length and 3 feet wide. It has 18,240 LEDs. There is an on/off switch that turns off after 30 minutes of use, and an AC to DC power supply.
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