K222205 is an FDA 510(k) clearance for the Cold Sore Device (Model: QPZ-01). This device is classified as a Light Based Treatment For Cold Sores Herpes Simplex Virus-1 (Class II - Special Controls, product code OKJ).
Submitted by Light Tree Ventures Europe B.V. (Hague, NL). The FDA issued a Cleared decision on October 7, 2022, 74 days after receiving the submission on July 25, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4860. Shortens Time To Healing Of Herpes Simplex Lesions On The Lips, With Time To Healing Defined As The Time To Patient Described Re-epithelialization..
| 510(k) Number | K222205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2022 |
| Decision Date | October 07, 2022 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OKJ - Light Based Treatment For Cold Sores Herpes Simplex Virus-1 |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4860 |
| Definition | Shortens Time To Healing Of Herpes Simplex Lesions On The Lips, With Time To Healing Defined As The Time To Patient Described Re-epithelialization. |