K253153 is an FDA 510(k) clearance for the SER Pen Carain MicroSystem (MP1209SP). This device is classified as a Powered Microneedle Device (Class II - Special Controls, product code QAI).
Submitted by Su-Ko Technologies, LLC (Austin, US). The FDA issued a Cleared decision on October 29, 2025, 33 days after receiving the submission on September 26, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4430. A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use..
| 510(k) Number | K253153 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 26, 2025 |
| Decision Date | October 29, 2025 |
| Days to Decision | 33 days |
| Submission Type | Special |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QAI - Powered Microneedle Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4430 |
| Definition | A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use. |