SCS

Ultraviolet Radiation Disinfection Chamber Device

Product code
SCS
Device name
Ultraviolet Radiation Disinfection Chamber Device
Device class
Class 2
21 CFR
21 CFR 880.6511
Medical specialty
General Hospital
Marketing pathway
510(K)
510(k) clearances (last 3 years)
2
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2026-01-29.

NumberDecision dateApplicantDevice nameSummary
K2513542026-01-29UV Smart Technologies B.V.UV Smart D60PDF
DEN2300672024-08-28GermitecChronos®

1 summaries are archived here for direct download.

Official FDA classification page: SCS
Classification and pathway per current FDA publications. Data from openFDA (CC0).