De Novo DEN090012
- Device
- VIRULITE COLD SORE MACHINE
- Contact
- beky pine
- De Novo number
- DEN090012
- Product code
- OKJ
- Regulation
- 878.4860
- Classification name
- light based treatment for cold sores herpes simplex virus-1
- Decision
- granted (DENG)
- Decision date
- 2012-10-18
- Date received
- 2009-06-30
- Classification advisory
- General & Plastic Surgery
- Review advisory
- General & Plastic Surgery
- Type
- Post-NSE
Current FDA Classification#
- Product code
- OKJ
- Device name
- Light Based Treatment For Cold Sores Herpes Simplex Virus-1
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation
- 878.4860
- Implant
- N
- Life sustain/support
- N