| DeNovo ID | DEN150005 |
| Device Name: | Newa Skin Therapy System |
| Classification | Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction |
| Applicant | EndyMed Medical Ltd. 12 Leshem Street, North Industrial Park Caesarea, IL 30889 |
| Contact | Yoram Levy |
| Product Code | PAY |
| CFR Regulation Number | 878.4420 [🔎] |
| 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 | 2015-01-16 |
| Decision Date | 2015-12-18 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |