K240226
- 510(k) number
- K240226
- Device name
- Pixie Skin Tag
- Applicant
- Oystershell NV BE
- Product code
- ORE not yet in the FDA classification database
- Decision date
- 2024-10-18
- Date received
- 2024-01-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K240226.pdf
Official FDA record: K240226
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.