Search Results
Found 1 results
510(k) Data Aggregation
K Number
K170489Device Name
Skylit Phototherapy System
Manufacturer
Skylit Medical
Date Cleared
2017-05-23
(95 days)
Product Code
FTC
Regulation Number
878.4630Why did this record match?
Applicant Name (Manufacturer) :
Skylit Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).
Device Description
The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device. It is indicated for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories:
- Handheld UV light Emission device that delivers the UVB light
- Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
- Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.
Ask a Question
Page 1 of 1