Walgreens

Primary DI
00311917065007
Brand
Walgreens
Company
WALGREEN CO.
Model
845575
Device description
Walgreens Reusable Cold Sore Treatment Device with Infrared Light Technology
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K222205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222205000Cold Sore Device (Model: QPZ-01)Light Tree Ventures Europe B.V.2022-10-07OKJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10311917065004PackageGS110In Commercial Distribution
00311917065007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031191706500410311917065004
00311917065007003119170650073119170650070311917065007

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

Contacts#

Phone, Email table
PhoneEmail
1-786-786-1250consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08
00311917085753Walgreens7208922026-05-08
00311917085760Walgreens7208972026-05-08
00311917077598Walgreens7377342026-04-28
00311917151434Walgreens2205442019-11-29
00311917151472Walgreens2205502019-11-28
00311917219288Walgreens2729422020-11-26
00311917219295Walgreens2729432020-11-26
00311917064635Walgreens351587 2025-06-20
00311917006239Walgreens2964622023-01-25
00311917065724Walgreens8246332025-04-29
00311917065731Walgreens8246322025-04-29
00311917065762WALGREENS8416972025-04-29
00311917065779WALGREENS7456072025-04-29
00311917066585WALGREENS8360682025-04-29
00311917199603WALGREENS8281472022-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063220064Luminance RED Cold Sore DeviceLuminance Medical Ventures IncorporatedOKJ2026-01-27
10311917065004WalgreensWALGREEN CO.OKJ2025-07-15
00311917130347WALGREENSWALGREEN CO.OKJ2023-03-06
10031191713032WALGREENSWALGREEN CO.OKJ2023-03-06