510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K200971Substantially Equivalent

308nm Excimer System

Xuzhou Kernel Medical Equipment Co Ltd, Xuzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200971 is the FDA 510(k) clearance record for 308nm Excimer System, a class II device, cleared for Xuzhou Kernel Medical Equipment Co., Ltd. on under FDA product code FTC (Light, Ultraviolet, Dermatological). FDA records list 9 510(k) clearances for Xuzhou Kernel Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K200971.

Clearance record

Decision date
Received
(246 days to decision)
Product code
FTC Light, Ultraviolet, Dermatological
Regulation
21 CFR 878.4630
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd. Kernel Mansion, Economic Development District, Xuzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FTC

Trailing 12 months
2 clearances under product code FTC in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FTC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260