| DeNovo ID | DEN160029 |
| Device Name: | SkinPen Precision System |
| Classification | Powered Microneedle Device |
| Applicant | BELLUS MEDICAL, LLC. 12001 N. Central Expwy. Dallas, TX 75243 |
| Contact | Jennifer Block |
| Product Code | QAI |
| CFR Regulation Number | 878.4430 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2016-07-05 |
| Decision Date | 2018-03-01 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |