K241400
- 510(k) number
- K241400
- Device name
- SkinPen Precision Elite System
- Applicant
- Crown Aesthetics TX · US
- Product code
- QAI — Powered Microneedle Device
- Decision date
- 2024-08-29
- Date received
- 2024-05-17
- 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: K241400.pdf
Official FDA record: K241400
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.