
Luminance Medical Ventures, Inc.
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Luminance Red Cold Sore Device (TN1927G) is an FDA 510(k)-cleared medical device (K251973) manufactured by Luminance Medical Ventures, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 22, 2025. Regulation: 8.