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510(k) Data Aggregation
K Number
K141181Device Name
NUVE FOR WRINKLES, DPL NUVE FOR WRINKLES
Manufacturer
LED TECHNOLOGIES, LLC
Date Cleared
2015-03-31
(328 days)
Product Code
OHS
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LED TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nive for Wrinkles is an Over-the-Counter (OTC) device intended for the use in treating full-face wrinkles.
Device Description
The Nüve for Wrinkles is an over-the-counter hand-held light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and fine lines. The device uses four types of LEDs : 605nm amber, 630nm red, 660nm red, and 880nm infrared. The treatment time is controlled by the user. There are no user settings or adiustments required.
The Nuve for Wrinkles system components include the handheld unit containing the LED module , power supply, goggles, and travel case.
The unit is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components. The device is sold as Over the Counter (OTC).
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K Number
K101382Device Name
DPL NUVE
Manufacturer
LED TECHNOLOGIES, LLC
Date Cleared
2010-11-09
(176 days)
Product Code
OHS, GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
LED TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Indicated as an over-the-counter phototherapy device for the treatment of mild to moderate acne.
Device Description
The dpl® Nüve is a lightweight, handheld, light emitting diode (LED) device with interchangeable heads which emit light energy. A blue LED head in the 415 nm spectrum is used in treatment for mild to moderate inflammatory acne. A red head at 625 nm and a purple head (infrared) in the 830 nm spectrum are used in combination for reduction of periorbital wrinkles. The handle of the device contains the electronics of the device including a fan for cooling and an automatic shut-off safety feature
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K Number
K081570Device Name
DPL THERAPY SYSTEM
Manufacturer
LED TECHNOLOGIES, LLC
Date Cleared
2008-11-07
(156 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
LED TECHNOLOGIES, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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 temporarily increase local blood circulation.
Device Description
The DPL ™ Therapy System is a compact infrared lamp for therapeutic heating. It delivers infrared light to the skin resulting in a safe elevation of the skin temperature for therapeutic effects. The device is comparable in design, technology, and output to the Dermillume HR 1000 infrared lamp product. The lamps are contained in two panels on a desk stand. The panels are detachable for use individually or as a pair on the body. The product has an automatic 17-minute timed cycle which may be repeated by activating the ON cycle. Device takes 8 minutes to reach target temperature on skin. Total time for treatment is 17 minutes.
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