Luminance Red Cold Sore Device (TN1927G)
K-Number: K251973 · 2025-09-23
ApplicantLuminance Medical Ventures, Inc.
Decision Date2025-09-23
Product CodeOKJ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Luminance Red Cold Sore Device (TN1927G) is a medical device manufactured by Luminance Medical Ventures, Inc.. It received FDA 510(k) clearance on 2025-09-23 under approval number K251973. The device is classified under product code OKJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Luminance Red Cold Sore Device (TN1927G)?
Luminance Red Cold Sore Device (TN1927G) is a medical device that received FDA 510(k) clearance on 2025-09-23. It is manufactured by Luminance Medical Ventures, Inc.. The 510(k) number is K251973.
When was Luminance Red Cold Sore Device (TN1927G) approved by the FDA?
Luminance Red Cold Sore Device (TN1927G) received FDA 510(k) clearance on 2025-09-23, under approval number K251973.
What company makes Luminance Red Cold Sore Device (TN1927G)?
Luminance Red Cold Sore Device (TN1927G) is manufactured by Luminance Medical Ventures, Inc..
What is the FDA product code for Luminance Red Cold Sore Device (TN1927G)?
The FDA product code for Luminance Red Cold Sore Device (TN1927G) is OKJ.
Related Clinical Trials
Other Devices by Luminance Medical Ventures, Inc.
Related Devices (Code: OKJ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.