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510(k) K251354

UV Smart D60 by UV Smart Technologies B.V. — Product Code SCS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2026
Date Received
April 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ultraviolet Radiation Disinfection Chamber Device
Device Class
Class II
Regulation Number
880.6511
Review Panel
HO
Submission Type

An ultraviolet radiation disinfection chamber device is intended to disinfect patient contacting medical devices using UV radiation after the device has been cleaned. Disinfection of the medical device is achieved within an enclosed chamber through the exposure to UV radiation.

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