Cold Sore Device (Model: QPZ-01)
FDA 510(k) clearance K222205 · decided 2022-10-07
Clearance details
- K-number
- K222205
- Device name
- Cold Sore Device (Model: QPZ-01)
- Applicant
- Light Tree Ventures Europe B.V.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-25
- Decision date
- 2022-10-07
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- OKJ
- Device class
- 2
- Regulation number
- 878.4860
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Hague, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Luminance Red Cold Sore Device (TN1927G) (K251973) | Luminance Medical Ventures, Inc. | 2025-09-23 |
| Cold Sore Device (QPZ-03) (K241155) | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024-09-05 |
| VIRULITE COLD SORE MACHINE (DEN090012) | Virulite, LLC | 2012-10-18 |
Recalls involving this device
No recalls on record reference this clearance.