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510(k) K251973

Luminance Red Cold Sore Device (TN1927G) by Luminance Medical Ventures, Inc. — Product Code OKJ

K251973 is an FDA 510(k) premarket notification submitted by Luminance Medical Ventures, Inc. for the device "Luminance Red Cold Sore Device (TN1927G)". The FDA issued a decision of Substantially Equivalent on September 23, 2025. The device falls under product code OKJ (Light Based Treatment For Cold Sores Herpes Simplex Virus-1), a Class II device regulated under 21 CFR 878.4860. Luminance Medical Ventures, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2025
Date Received
June 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Device Class
Class II
Regulation Number
878.4860
Review Panel
SU
Submission Type

Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.

Other clearances by Luminance Medical Ventures, Inc.

  • K220729 — The Luminance RED Acne Device (June 9, 2022)

Other clearances for product code OKJ

  • K241155 — Cold Sore Device (QPZ-03) (September 5, 2024)
  • K222205 — Cold Sore Device (Model: QPZ-01) (October 7, 2022)
  • DEN090012 — VIRULITE COLD SORE MACHINE (October 18, 2012)

FDA data resources