510(k) DEN090012
- Device
- VIRULITE COLD SORE MACHINE
- Applicant
- Virulite, LLC
- 510(k) number
- DEN090012
- Product code
- OKJ
- Decision
- Unknown (DENG)
- Decision date
- 2012-10-18
- Date received
- 2009-06-30
- Regulation
- 878.4860
- Classification name
- Light Based Treatment For Cold Sores Herpes Simplex Virus-1
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- BEKY PINE
- Address
- 5405 Alton Pkwy., 5a Suite 530 Irvine CA US 92604 92604
FDA Registration Numbers#
- 3018949797
- 3011644607
- 3020491484
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OKJ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251973 | Luminance Red Cold Sore Device (TN1927G) | Luminance Medical Ventures, Inc. | 2025-09-23 |
| K241155 | Cold Sore Device (QPZ-03) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-09-05 |
| K222205 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022-10-07 |