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510(k) K250425

Ultraviolet Phototherapy Device by APK Technology Co., Ltd. — Product Code FTC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 2025
Date Received
February 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light, Ultraviolet, Dermatological
Device Class
Class II
Regulation Number
878.4630
Review Panel
SU
Submission Type

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