The following data is part of a premarket notification filed by Endymed Medical Ltd. with the FDA for Endymed Contour Handpiece.
| Device ID | K161199 |
| 510k Number | K161199 |
| Device Name: | EndyMed Contour Handpiece |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | ENDYMED MEDICAL LTD. 12 LESHEM STREET NORTH INDUSTRIAL PARK Caesarea, IL 3088900 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy QSITE 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-28 |
| Decision Date | 2016-08-01 |
| Summary: | summary |