K243800 is an FDA 510(k) clearance for the PRO Pen Microneedling System (6883). This device is classified as a Powered Microneedle Device (Class II - Special Controls, product code QAI).
Submitted by Dermalogica, LLC (Carson, US). The FDA issued a Cleared decision on August 25, 2025, 257 days after receiving the submission on December 11, 2024.
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 | K243800 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2024 |
| Decision Date | August 25, 2025 |
| Days to Decision | 257 days |
| Submission Type | Traditional |
| 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. |