Definition: Shortens The Time To Healing As Compared To Untreated Cold Sores. This Is A Treatment Of Individual Herpes Labialis Lesions In Persons Infected With The Herpes Simplex Virus.
| Device Type ID | 5809 |
| Device Name | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
| Physical State | Uses A 1072nm +/- 12nm Peak Wavelength On A Cold Sore For A Period Of Approximately 3 Minutes. The Power Source Is A Standard Alkaline 9v Battery, Which Is Replaceable. Treatment With The Cold Sore Machine Is Commenced At The First Symptoms Of A Cold |
| Technical Method | Applies Low Level Light To A Herpes Simplex Virus Cold Sore On The Lips. The Light Shortens The Healing Time Of The Cold Sore. |
| Target Area | Lips |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4850 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OKJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5809 |
| Device | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
| Product Code | OKJ |
| FDA Device Classification | Class 2 Medical Device |
| CFR Regulation Number | 878.4850 [🔎] |