510(k) K241155
K241155 is an FDA 510(k) premarket notification submitted by Shenzhen Nuon Medical Equipment Co., Ltd. for the device "Cold Sore Device (QPZ-03)". The FDA issued a decision of Substantially Equivalent on September 5, 2024. The device falls under product code OKJ (Light Based Treatment For Cold Sores Herpes Simplex Virus-1), a Class II device regulated under 21 CFR 878.4860. Shenzhen Nuon Medical Equipment Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2024
- Date Received
- April 25, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Treatment For Cold Sores Herpes Simplex Virus-1
- Device Class
- Class II
- Regulation Number
- 878.4860
- Review Panel
- SU
- Submission Type
Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.