Luminance RED Cold Sore Device

Primary DI
00850063220064
Brand
Luminance RED Cold Sore Device
Company
Luminance Medical Ventures Incorporated
Model
TN1927G
Published
2026-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-1

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OKJLight Based Treatment For Cold Sores Herpes Simplex Virus-1General, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251973000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251973000Luminance Red Cold Sore Device (TN1927G)Luminance Medical Ventures, Inc.2025-09-23OKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850063220064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850063220064008500632200648500632200640850063220064

GMDN Terms#

Term, Definition table
TermDefinition
Infrared-light cold sore treatment deviceA hand-held, battery-powered, portable device designed to be used by a layperson to emit infrared light intended as therapy to reduce the duration of cold sores caused by the herpes virus (herpes labialis). It typically consists of a self-contained unit, light-emitting diodes (LEDs), an internal microprocessor and software, activation control and signal light, and disposable batteries. Upon application, it emits infrared light (wavelengths around 1072 nm) to the dermis of the affected area of an erupting cold sore for a pre-set period of time (e.g., few minutes) and provides a signal to the user when the treatment is complete.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065554288
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009581784The Luminance RED - Genital Sore PRO DeviceTN1927F2025-04-04
00860002593005Luminance RED Lip DeviceTN1927A2023-05-26
00860002593043Luminance RED Mouth DeviceTN1927B2023-05-26
00860002593050Luminance RED Genital DeviceTN1927C2023-05-26
00860002593074Luminance RED TipBE-NQUQ-FSF82023-05-26
00860002593036Luminance RED Acne DeviceTN1927D2023-05-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10311917065004WalgreensWALGREEN CO.OKJ2025-07-15
00311917065007WalgreensWALGREEN CO.OKJ2025-07-15
00311917130347WALGREENSWALGREEN CO.OKJ2023-03-06
10031191713032WALGREENSWALGREEN CO.OKJ2023-03-06