DeviceClearance

Product code OKJ— General, Plastic Surgery

Cold Sore Device (Model: QPZ-01)

Classification name
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Device class
Class 2
Regulation
21 CFR 878.4860
Advisory panel
General, Plastic Surgery
Total cleared
4
First cleared
Most recent

FDA classification definition

“Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.”

— U.S. Food and Drug Administration, device classification record for product code OKJ under 21 CFR 878.4860, via openFDA

Market context for product code OKJ

FDA has cleared 4 devices under product code OKJ between 2012 and 2025, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OKJ

Recent clearances under product code OKJ

Data sourced from openFDA. This site is unofficial and independent of the FDA.