510(k) K261775

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB) by Xuzhou Kernel Medical Equipment Co., Ltd.

K261775 is an FDA 510(k) premarket notification submitted by Xuzhou Kernel Medical Equipment Co., Ltd. for the device "Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)". The FDA issued a decision of Substantially Equivalent on July 21, 2026. Xuzhou Kernel Medical Equipment Co., Ltd. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2026
Date Received
May 29, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No