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
Product Codes
| Code | Name |
|---|
| OKJ | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| OKJ | Light Based Treatment For Cold Sores Herpes Simplex Virus-1 | General, Plastic Surgery | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K222205 | 000 | Cold Sore Device (Model: QPZ-01) | Light Tree Ventures Europe B.V. | 2022-10-07 | OKJ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10311917065004 | Package | GS1 | 10 | In Commercial Distribution |
| 00311917065007 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Infrared-light cold sore treatment device | A 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. |
Contacts
| Phone | Email |
|---|
| 1-786-786-1250 | consumerrelations.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
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850063220064 | Luminance RED Cold Sore Device | Luminance Medical Ventures Incorporated | OKJ | 2026-01-27 |
| 00311917065007 | WALGREENS | LIGHT TREE TECHNOLOGY INDIA PRIVATE LIMITED | OKJ | 2025-06-23 |
| 10031191713032 | WALGREENS | WALGREEN CO. | OKJ | 2023-03-06 |