Cleared Traditional

K261775 - Uv Phototherapy (KN-4001A

K261775 · Xuzhou Kernel Medical Equipment Co., Ltd. · General & Plastic Surgery device
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Jul 2026
Decision
53d
Days
-
Risk

K261775 is an FDA 510(k) clearance for the Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB).

Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on July 21, 2026 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xuzhou Kernel Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K261775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2026
Decision Date July 21, 2026
Days to Decision 53 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 115d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -