Cleared Traditional

K251973 - Luminance Red Cold Sore Device (TN1927G) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251973 · Luminance Medical Ventures, Inc. · General & Plastic Surgery device
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Sep 2025
Decision
89d
Days
Class 2
Risk

K251973 is an FDA 510(k) clearance for the Luminance Red Cold Sore Device (TN1927G). Classified as Light Based Treatment For Cold Sores Herpes Simplex Virus-1 (product code OKJ), Class II - Special Controls.

Submitted by Luminance Medical Ventures, Inc. (Dallas, US). The FDA issued a Cleared decision on September 23, 2025 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4860 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Luminance Medical Ventures, Inc. devices

Submission Details

510(k) Number K251973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2025
Decision Date September 23, 2025
Days to Decision 89 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 114d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4860
Definition Shortens Time To Healing Of Herpes Simplex Lesions On The Lips, With Time To Healing Defined As The Time To Patient Described Re-epithelialization.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Medlaunch, LLC
Nathan Glass

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.