FDA Product Code OKJ: Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Shortens Time To Healing Of Herpes Simplex Lesions On The Lips, With Time To Healing Defined As The Time To Patient Described Re-epithelialization.
Leading manufacturers include Light Tree Ventures Europe B.V., Shenzhen Nuon Medical Equipment Co., Ltd. and Luminance Medical Ventures, Inc..
FDA 510(k) Cleared Light Based Treatment For Cold Sores Herpes Simplex Virus-1 Devices (Product Code OKJ)
About Product Code OKJ - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OKJ since 2012, with 3 receiving FDA clearance (average review time: 376 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OKJ have taken an average of 111 days to reach a decision - down from 640 days historically, suggesting improved FDA processing for this classification.
OKJ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →