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510(k) K251973

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

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.