K253153
- 510(k) number
- K253153
- Device name
- SER Pen Carain MicroSystem (MP1209SP)
- Applicant
- Su-Ko Technologies, LLC TX · US
- Product code
- QAI — Powered Microneedle Device
- Decision date
- 2025-10-29
- Date received
- 2025-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253153.pdf
Official FDA record: K253153
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.