FDA.reportPublic FDA data

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

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
00311917034218Walgreens7654302023-07-11
00311917034249Walgreens7654262023-07-11
00311917077932Walgreens7394332026-10-14
00311917090498Walgreens4172342026-10-12
00311917088556Walgreens3119170885562026-09-30
00311917086521Walgreens1439332026-09-28
00311917156064WALGREENS2576322020-07-22
00311917080062Walgreens7610162026-08-26
00311917086569Walgreens1666772026-08-21
00311917086590Walgreens1666372026-08-21
00311917122045Walgreens5052882023-03-09
00311917158952Walgreens276743WRX2767432020-07-14
00311917014876Walgreens6772599288502016-12-20
00311917048130Walgreens6548789288562016-12-20
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08

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