510(k) K222205
K222205 is an FDA 510(k) premarket notification submitted by Light Tree Ventures Europe B.V. for the device "Cold Sore Device (Model: QPZ-01)". The FDA issued a decision of Substantially Equivalent on October 7, 2022. 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. Light Tree Ventures Europe B.V. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 7, 2022
- Date Received
- July 25, 2022
- 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.