FDA product code OKJ

Light Based Treatment For Cold Sores Herpes Simplex Virus-1

General, Plastic Surgery·Class 2·21 CFR 878.4860
US regulatory classifications
US Product Code (FDA)
OKJ
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4860
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not 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.

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About this record

Light Based Treatment For Cold Sores Herpes Simplex Virus-1 is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.