K251973
- 510(k) number
- K251973
- Device name
- Luminance Red Cold Sore Device (TN1927G)
- Applicant
- Luminance Medical Ventures, Inc. TX · US
- Product code
- OKJ — Light Based Treatment For Cold Sores Herpes Simplex
- Decision date
- 2025-09-23
- Date received
- 2025-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K251973.pdf
Official FDA record: K251973
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.