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510(k) K241155

Device
Cold Sore Device (QPZ-03)
Applicant
Shenzhen Nuon Medical Equipment Co., Ltd.
510(k) number
K241155
Product code
OKJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-05
Date received
2024-04-25
Regulation
878.4860
Classification name
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Alain Dijkstra
Address
1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St., Baoan Dist Shenzhen CN 518000 518000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OKJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251973Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc.2025-09-23
K222205Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V.2022-10-07
DEN090012VIRULITE COLD SORE MACHINEVirulite, LLC2012-10-18