K241155
- 510(k) number
- K241155
- Device name
- Cold Sore Device (QPZ-03)
- Applicant
- Shenzhen Nuon Medical Equipment Co., Ltd. CN
- Product code
- OKJ — Light Based Treatment For Cold Sores Herpes Simplex
- Decision date
- 2024-09-05
- Date received
- 2024-04-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241155.pdf
Official FDA record: K241155
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.