510(k) K191571

UV Radiation Treatment System by Xuzhou Yongkang Electronic Science Technology Co., Ltd. — Product Code FTC

K191571 is an FDA 510(k) premarket notification submitted by Xuzhou Yongkang Electronic Science Technology Co., Ltd. for the device "UV Radiation Treatment System". The FDA issued a decision of Substantially Equivalent on February 6, 2020. The device falls under product code FTC (Light, Ultraviolet, Dermatological), a Class II device regulated under 21 CFR 878.4630. Xuzhou Yongkang Electronic Science Technology Co., Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 6, 2020
Date Received
June 14, 2019
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