VIRULITE COLD SORE MACHINE
FDA 510(k) clearance DEN090012 · decided 2012-10-18
Clearance details
- K-number
- DEN090012
- Device name
- VIRULITE COLD SORE MACHINE
- Applicant
- Virulite, LLC
- Decision
- Unknown
- Date received
- 2009-06-30
- Decision date
- 2012-10-18
- Days to decision
- 1206 days
- Clearance type
- Post-NSE
- Product code
- OKJ
- Device class
- 2
- Regulation number
- 878.4860
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Luminance Red Cold Sore Device (TN1927G) (K251973) | Luminance Medical Ventures, Inc. | 2025-09-23 |
| Cold Sore Device (QPZ-03) (K241155) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-09-05 |
| Cold Sore Device (Model: QPZ-01) (K222205) | Light Tree Ventures Europe B.V. | 2022-10-07 |
Recalls involving this device
No recalls on record reference this clearance.