510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN090012Unknown

Virulite Cold Sore Machine

Virulite, LLC, Irvine CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN090012 is the FDA 510(k) clearance record for VIRULITE COLD SORE MACHINE, a class II device, cleared for Virulite, LLC on under FDA product code OKJ (Light Based Treatment For Cold Sores Herpes Simplex Virus-1). FDA's definition for product code OKJ reads: "Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization". FDA records list one 510(k) clearance for Virulite, LLC. As of , FDA records show no recalls naming DEN090012.

Clearance record

Decision date
Received
(1,206 days to decision)
Product code
OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Regulation
21 CFR 878.4860
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Virulite, LLC 5405 Alton Pkwy., 5a, Irvine CA
Third party review
No

Clearances, product code OKJ

Trailing 12 months

FDA records hold no clearances under product code OKJ in the trailing twelve months.

FDA records show no clearances under product code OKJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OKJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260