FDA.reportPublic FDA data

Walgreens

Primary DI
10311917065004
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
Rx
false
OTC
true
Sterile
false
Single use
false

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00311917065007WalgreensWALGREEN CO.OKJ2025-07-15
00311917130347WALGREENSWALGREEN CO.OKJ2023-03-06
10031191713032WALGREENSWALGREEN CO.OKJ2023-03-06