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510(k) Data Aggregation
K Number
K180900Device Name
LED Light Therapy Device
Manufacturer
Uvbiotek, LLC
Date Cleared
2018-07-10
(95 days)
Product Code
OLP
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Uvbiotek, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LED Light Therapy Device is indicated for the treatment of mild to moderate inflammatory acne.
Device Description
The LED Light Therapy Device is a lightweight device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the spectrum (633±10nm) and/or in the blue light region of the spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. This device is made up of a main unit and therapy head. The light gathering cover is also referred to as the snoot. The snoot helps to establish the correct treatment distance.
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K Number
K170187Device Name
Photodynamic Therapy Device
Manufacturer
UVBIOTEK, LLC
Date Cleared
2017-07-28
(186 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
UVBIOTEK, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Photodynamic Therapy Device combination of Red (633nm=10mm) and Blue (417nm=10mm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Device Description
The Photodynamic Therapy Device KN-7000A is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs), to manage aesthetic conditions. The device produces light in the red light region of the light spectrum (633±10mm) and/or in the blue light region of the light spectrum (417±10nm), intended to help reduce the appearance of mild to moderate acne. There are three irradiators available, Blue LED, Red LED and Blue/Red LED. This device is mainly made up of the main frame, the irradiator, and the lifting stand.
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