K240226 is an FDA 510(k) clearance for the Pixie Skin Tag..
Submitted by Oystershell NV (Merelbeke, BE). The FDA issued a Cleared decision on October 18, 2024, 266 days after receiving the submission on January 26, 2024.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K240226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2024 |
| Decision Date | October 18, 2024 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | ORE |
| Device Class | - |