510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K132643Substantially Equivalent

UV Phototherapy

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

K132643 is the FDA 510(k) clearance record for UV PHOTOTHERAPY, 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 K132643.

Clearance record

Decision date
Received
(157 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. P.O. Box 120-119, Shanghai, 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