The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Ultrashape Power System.
| Device ID | K170370 |
| 510k Number | K170370 |
| Device Name: | ULTRASHAPE POWER SYSTEM |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | Syneron Medical Ltd. Tavor Building, Industrial Zone, P.O.B. 550 Yokneam Illit, IL 20692 |
| Contact | Ruthie Amir |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, PA 19103 |
| Product Code | OHV |
| CFR Regulation Number | 878.4590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-05-15 |
| Summary: | summary |