Luminance RED Cold Sore Device
Model TN1927G · Luminance Medical Ventures Incorporated · DI 00850063220064
OKJ — Light Based Treatment For Cold Sores Herpes Simplex Virus-1 · Class II · 21 CFR 878.4860
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- K251973 SESE 2025-09-23 (k number procode)
Predicate lineage
K251973 — cites (transitively): K222205 (d1), DEN090012 (d2), K083767 (d2)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Luminance Medical Ventures Incorporated
- OAI 2025-04-08 Luminance Medical Ventures Incorporated · 2 citations
- OAI 2025-04-08 Luminance Medical Ventures Incorporated · 2 citations