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510(k) Data Aggregation
K Number
K230076Device Name
Enhanced AURORA Medical Diode System, and related accessories
Manufacturer
Psoria-Shield, Inc.
Date Cleared
2023-03-08
(57 days)
Product Code
FTC, GEX
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Psoria-Shield, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
Device Description
The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area.
The device is comprised of four main components:
- A base station
- A touchscreen where the user can enter system commands
- Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece.
- A printer accessory that can print out verification of treatment parameters for hard copy records.
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