Luminance Red Cold Sore Device (TN1927G)
FDA 510(k) clearance K251973 · decided 2025-09-23
Clearance details
- K-number
- K251973
- Device name
- Luminance Red Cold Sore Device (TN1927G)
- Applicant
- Luminance Medical Ventures, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-26
- Decision date
- 2025-09-23
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- OKJ
- Device class
- 2
- Regulation number
- 878.4860
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dallas, TX, 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 |
|---|---|---|
| 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 |
| VIRULITE COLD SORE MACHINE (DEN090012) | Virulite, LLC | 2012-10-18 |
Recalls involving this device
No recalls on record reference this clearance.