510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241155Substantially Equivalent

Cold Sore Device (QPZ-03)

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

K241155 is the FDA 510(k) clearance record for Cold Sore Device (QPZ-03), a class II device, cleared for Shenzhen Nuon Medical Equipment Co., Ltd. on under FDA product code OKJ (Light Based Treatment For Cold Sores Herpes Simplex Virus-1). FDA's definition for product code OKJ reads: "Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization". FDA records list 5 510(k) clearances for Shenzhen Nuon Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K241155.

Clearance record

Decision date
Received
(133 days to decision)
Product code
OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Regulation
21 CFR 878.4860
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Shenzhen Nuon Medical Equipment Co., Ltd. 1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St.,, Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OKJ

Trailing 12 months

FDA records hold no clearances under product code OKJ in the trailing twelve months.

FDA records show no clearances under product code OKJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OKJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260