Clearance Summary
VIRULITE COLD SORE MACHINE received FDA 510(k) clearance under submission number DEN090012, sponsored by Virulite, LLC. The device was reviewed via the Post-NSE premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-10-18.
- Submission: DEN090012
- Applicant / Sponsor: Virulite, LLC
- Clearance pathway: Post-NSE
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4860
- Decision date: 2012-10-18
Classification & Regulation
This clearance is catalogued under FDA product code OKJ and 21 CFR 878.4860, within the General, Plastic Surgery review panel as a Class II device.