K241155 is an FDA 510(k) clearance for the Cold Sore Device (QPZ-03), a Light Based Treatment For Cold Sores Herpes Simplex Virus-1 (Class II — Special Controls, product code OKJ), submitted by Shenzhen Nuon Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on September 5, 2024, 133 days after receiving the submission on April 25, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4860.
| 510(k) Number | K241155 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 25, 2024 |
| Decision Date | September 05, 2024 |
| Days to Decision | 133 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. |