Search Results
Found 2 results
510(k) Data Aggregation
K Number
K191086Device Name
Exciplex
Manufacturer
Clarteis
Date Cleared
2019-12-11
(231 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Clarteis
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The exciplex® is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. The reusable polycarbonate/ABS reduction tips and reusable silicone masks are for use on intact skin only.
Device Description
The Exciplex is a compact handheld excimer device that emits a narrow-band UVB light at 308 nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously delivered through a 5x5 cm² output window at an irradiance of 100 mW/cm². Treatments are performed by applying the output window over the affected area with the help of reduction tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light pulses where the device is used multiple times along the affected area.
Ask a Question
K Number
K171702Device Name
Exciplex308nm
Manufacturer
Clarteis
Date Cleared
2017-10-13
(127 days)
Product Code
FTC, GEX
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Clarteis
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Exciplex308nm is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Device Description
The Exciplex 308m" is a compact handheld excimer device that emits a narrow-band UVB light at 308nm. This ultraviolet wavelength of light is known to be beneficial in the treatment of various dermatological conditions such as psoriasis and vitiligo. The UVB light is homogeneously delivered through a 5x5cm² output window at an irradiance of 100mW/cm². Treatments are performed by applying the output window over the affected area with the help of treatment tips or silicone masks to shield the surrounding healthy skin. A treatment might consist of a series of light "shots" where the device is used multiple times along the affected area.
Ask a Question
Page 1 of 1