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Found 9 results
510(k) Data Aggregation
K Number
K151336Device Name
LightStim Professional 2-Panel Light
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2015-10-23
(157 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 Professional System #3A panel is intended for the treatment of full-face wrinkles.
The LightStim Professional System #3B panel is intended for the treatment of mild to moderate acne.
The LightStim Professional System #4 panel is intended for the treatment of mild to moderate acne.
Device Description
The LightStim Professional 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1.130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42" reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.
The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.
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K Number
K151333Device Name
LightStim for Pain LED Belt
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2015-08-21
(94 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 for Pain LED Belt is an Over-The-Counter device intended to emit energy in the visible and near infrared spectrum 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 for Pain LED Belt is a portable device that has between one and four separate LED pods, each of which has 52 LEDs and are attached to a elastic belt that stretches to encircle different sizes from as small as an ankle to as large as the torso, and attaches to itself with Velcro. Each pod has an LED array of 630nm, 865nm, and 940nm. The device is powered by a separate AC to DC 12-volt power supply and has an on/off switch, with a timer that shuts the device off automatically after 30 minutes of operation. Recommended treatment time is 5 to 30 minutes.
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K Number
K150098Device Name
LightStim Professional 2-Panel Light
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2015-04-09
(79 days)
Product Code
OHS, ILY
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 Professional 2-Panel Light System has two (2) interchangeable 2-Panel LED Systems, each mounted on a hands-free, fully articulating arms:
System #1- emitting energy in the visible and IR spectrums intended for use in the treatment of full-face wrinkles.
System #2 - emitting 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 2-Panel Light System is a portable device that has two (2) separate interchangeable 2-panel treatment heads, each containing 1,130 LEDs. Each treatment heads is attached to a fully retractable and articulating arm with a 42″ reach. Either one of these arms can be attached to the rolling stand for use. There is an on/off switch, and an AC to DC power supply.
The LightStim 2-Panel Light System is intended to be operated only by a person who has been personally trained by Company personnel. Each device includes a detailed Instruction Manual and includes one-on-one training and instruction by Company training staff. That training includes a thorough review of the Instruction Manual for the device and actual one-on-one training on the operation of the device with the end user.
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K Number
K142246Device Name
LightStim for Acne/ LightStim for Acne Mini
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2015-01-29
(168 days)
Product Code
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
LightStim for Acne/LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
Device Description
LightStim for Acne / LightStim for Acne Mini, model: LS4A/LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm and 630nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
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K Number
K131461Device Name
LIGHTSTIM FOR ACNE/ LIGHTSTIM FOR ACNE MINI
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2014-01-06
(231 days)
Product Code
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
LightStim for Acne Mini is an over-the-counter hand-held device intended for the use in the treatment of mild to moderate acne.
Device Description
LightStim for Acne Mini, model: LS4AM is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide illumination which comes in contact with the skin. The device components include LED's of 415nm, a hand piece, a printed circuit board, an on/off switch, a resistor, a receiver jack in the hand piece to plug a power supply into and a separate AC to DC (9 volt) power supply. Treatment time is recommended to be three to four minutes and is controlled by the user.
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K Number
K120775Device Name
LIGHT FOR WRINKLES
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2012-06-04
(82 days)
Product Code
OHS
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 for Wrinkles is an over-the-counter hand-held device intended for the use in the treatment of full-face wrinkles
Device Description
The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light emitting diodes (LED's) that emit Low and Sub IR light for direct exposure to the skin. The components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelength, a (non-flammable plastic) hand piece housing, a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with a resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
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K Number
K101190Device Name
LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2010-07-01
(64 days)
Product Code
OHS
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 Light for Winkles is an Over-The-Counter handheld device intended for use in the treatment of periorbital wrinkles.
Device Description
The Light for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of low intensity light emitting diodes (LED's) that emit Low and Sub-IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC (9-volt) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
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K Number
K092800Device Name
ANTI-WRINKLE (AGING) LIGHT, MODEL AAL
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2010-02-04
(146 days)
Product Code
ONE
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 Anti-Wrinkle Light, model: AAL, is a handheld device intended for use in the treatment of periorbital wrinkles.
The Anti-Wrinkle Light is a hand held device intended to emit energy in the visible and IR regions of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Device Description
The Anti-Wrinkle Light, Model AAL is a hand-held device consisting of low intensity light emitting diodes (LED's) that emit Low and Sub- IR light for direct exposure to the skin. The device components include an LED array of 605nm, 630nm, 660nm, and 855nm wavelengths, a (non-flammable plastic) hand piece housing a printed circuit board upon which the LED's are mounted, single non-timer on/off switch with 5-ohm resistor, receiver jack in the hand piece accommodating a removable power cord and a separate AC to DC ( 9-volt ) power supply. Treatment time is recommended to be 3 minutes and is controlled by the user.
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K Number
K083580Device Name
ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301
Manufacturer
LED INTELLECTUAL PROPERTIES, LLC
Date Cleared
2009-06-22
(201 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 Pain Therapy Light, model: PTL, is an Over-The-Counter hand held device intended to emit energy in the visible and near infrared spectrum 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 and blood circulation, and the temporary relaxation of muscles.
Device Description
Pain Therapy Light Model 1301 is a hand-held device consisting of low intensity light emitting diodes (LED's) that provide infra-red light to the skin. Physical components include an LED array emitting 630, 660, 855 and 940nm respectively in a handheld "wand" configuration containing a simple "in/out" integrated chip with external, manual on/off switch, a single electronic resistor, and a removable 9 volt AC-to-DC power supply. Treatment times are as required by the user, and specified by the User's Manuals for product code ILY indications.
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