The following data is part of a premarket notification filed by Syneron Medical Ltd with the FDA for Ultrashape Power System.
| Device ID | K160896 |
| 510k Number | K160896 |
| 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 | 2016-03-31 |
| Decision Date | 2016-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109952741 | K160896 | 000 |
| 07290109952147 | K160896 | 000 |
| 07290109950990 | K160896 | 000 |