FDA.reportPublic FDA data

WALGREENS

Primary DI
10031191713032
Brand
WALGREENS
Company
WALGREEN CO.
Model
QPZ-01
Device description
COLD SORE DEVICE REUSABLE
Published
2023-03-06
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
10031191713032PackageGS110In Commercial Distribution
00311917130347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1003119171303210031191713032
00311917130347003119171303473119171303470311917130347

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-844-968-3223consumerrelations.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
10311917065004WalgreensWALGREEN CO.OKJ2025-07-15
00311917065007WalgreensWALGREEN CO.OKJ2025-07-15
00311917130347WALGREENSWALGREEN CO.OKJ2023-03-06