K222205 is an FDA 510(k) clearance for the Cold Sore Device (Model: QPZ-01), 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 review panel. Regulated under 21 CFR 878.4860.
| 510(k) Number | K222205 FDA.gov |
| FDA Decision | Cleared 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. |