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510(k) Data Aggregation
K Number
K132518Device Name
NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE
Manufacturer
WELLQUEST INTL., INC.
Date Cleared
2014-08-17
(370 days)
Product Code
OHT, DEV, ONF
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
WELLQUEST INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Wellquest NuBrilliance Pulsed Light Hair Removal system device is an over-the-counter device intended for the removal of unwanted hair. The NuBrilliance Pulsed Light Hair Removal System is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of the treatment regimen.
Device Description
The NuBrilliance Pulsed Light Hair Removal System is a home-use, medical-esthetic device for long term Hair Reduction based on Intensive Pulse Light (IPL) technology. The NuBrilliance Pulsed Light Hair Removal System works below the skin's surface and therefore does not involve any cutting or pulling, reducing pain and preventing new hair growth. The NuBrilliance Pulsed Light Hair Removal System consists of the following main components: Base unit and applicator, Base-Applicator cable, and an AC cord.
The Base Unit comprises the User Interface (display/LEDs, buttons, etc.), the connection cable to the Applicator, the power cable to the grid as well as internal parts such electronics board/s and mechanical parts (fans, holders, etc.).
The Applicator is a hand held part used to remove unwanted body hair by applying the Nu Brilliance Pulsed Light Hair Removal treatment on areas such underarms, bikini line, arms and legs. It comprises a triggering button, a replaceable lamp sub-assembly, an optical safety feature as well as internal electro-mechanical parts.
The replaceable lamp cartridge is located inside the applicator inner body. The Base Unit provides the User Interface which includes the following controls:
- . Power on/off button
- . Energy level selection button ("-" or "+")
- Six energy level lights - lights up green when energy level is determined
- . Cartridge lamp – slowly flashes red when the cartridge requires replacement
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K Number
K973773Device Name
DAPELLE HAIR REMOVER
Manufacturer
WELLQUEST INTL., INC.
Date Cleared
1997-12-17
(76 days)
Product Code
KCX
Regulation Number
878.5360Why did this record match?
Applicant Name (Manufacturer) :
WELLQUEST INTL., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Intended use for this product is to remove unwanted hair.
Device Description
Not Found
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