510(k) DEN090012
DEN090012 is an FDA 510(k) premarket notification submitted by Virulite, LLC for the device "VIRULITE COLD SORE MACHINE". The FDA issued a decision of De Novo Granted on October 18, 2012. 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.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 18, 2012
- Date Received
- June 30, 2009
- Clearance Type
- Post-NSE
- 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.