K241355
- 510(k) number
- K241355
- Device name
- SER Pen Carain MicroSystem (MP1209SP)
- Applicant
- Su-Ko Technologies, LLC TX · US
- Product code
- QAI — Powered Microneedle Device
- Decision date
- 2024-10-09
- Date received
- 2024-05-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K241355.pdf
Official FDA record: K241355
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.