The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Ultrashape System.
| Device ID | K141708 |
| 510k Number | K141708 |
| Device Name: | ULTRASHAPE SYSTEM |
| Classification | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
| Applicant | SYNERON MEDICAL LTD. 1835 MARKET ST, 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SYNERON MEDICAL LTD. 1835 MARKET ST, 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 | 2014-06-24 |
| Decision Date | 2014-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109952451 | K141708 | 000 |
| 07290109952345 | K141708 | 000 |
| 07290109951812 | K141708 | 000 |
| 07290109951782 | K141708 | 000 |
| 07290109951171 | K141708 | 000 |
| 07290109951157 | K141708 | 000 |