510(k) K261775
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