Product code OKJ

Device name

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.4860

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset