The following data is part of a premarket notification filed by Endymion Medical Ltd with the FDA for Newa Skin Therapy System.
| Device ID | K130793 |
| 510k Number | K130793 |
| Device Name: | NEWA SKIN THERAPY SYSTEM |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ENDYMION MEDICAL LTD 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy ENDYMION MEDICAL LTD 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-22 |
| Decision Date | 2013-08-16 |
| Summary: | summary |