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510(k) DEN090012

VIRULITE COLD SORE MACHINE by Virulite, LLC — Product Code OKJ

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.