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

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