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510(k) Data Aggregation
K Number
K182215Device Name
ClearLink Controlled Phototherapy Equipment
Manufacturer
Daavlin Distributing Company
Date Cleared
2018-10-29
(75 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Daavlin Distributing Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.
Device Description
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The ClearLink Phototherapy Equipment delivers treatment, with Narrow Band UVB, Broad Band UVB and/or UVA ultraviolet light. Treatments are controlled through the ClearLink Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.
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K Number
K153749Device Name
3 Series Phototherapy Unit
Manufacturer
DAAVLIN DISTRIBUTING COMPANY
Date Cleared
2016-06-30
(184 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
DAAVLIN DISTRIBUTING COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3 Series NeoLux, full body phototherapy device, is a medical ultraviolet cabinet, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
Device Description
The 3 Series NeoLux Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The 3 Series NeoLux Phototherapy Unit delivers a 360 degree full body treatment, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and/or 350 nm (UVA), through an array of 24-48 fluorescent lamps. Treatments are controlled through the Soft Touch Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.
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K Number
K103708Device Name
ML24000 UVA-1 PHOTOTHERAPY UNIT
Manufacturer
THE DAAVLIN DISTRIBUTING COMPANY
Date Cleared
2011-02-22
(64 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
THE DAAVLIN DISTRIBUTING COMPANY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ML24000 UVA-1 Phototherapy Unit is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders.
Device Description
The ML24000 UVA-1 Phototherapy Unit is a microprocessor controlled full body ultraviolet light source, with spectral output at peak wavelengths of 370-390 nm. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders. The desired dose is selected using the operator interface located on the front panel of the device. The ML24000 UVA-1 Phototherapy Unit delivers full body phototherapy, wherebv Philips CLEO HPA 1018 Medium Pressure Lamps, which surround the patient, deliver the specified dose of UVA-1.
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