The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Velashape.
| Device ID | K071872 |
| 510k Number | K071872 |
| Device Name: | VELASHAPE |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692 |
| Contact | Yoni Iger |
| Correspondent | Yoni Iger SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-06 |
| Decision Date | 2007-08-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109952437 | K071872 | 000 |
| 07290109950358 | K071872 | 000 |
| 07290109950341 | K071872 | 000 |
| 07290109950334 | K071872 | 000 |
| 07290109950327 | K071872 | 000 |
| 07290109950310 | K071872 | 000 |
| 07290109950303 | K071872 | 000 |
| 07290109950266 | K071872 | 000 |
| 07290109950259 | K071872 | 000 |
| 07290109950242 | K071872 | 000 |
| 37290109952162 | K071872 | 000 |
| 37290109950359 | K071872 | 000 |
| 37290109950342 | K071872 | 000 |
| 07290109950440 | K071872 | 000 |
| 07290109950723 | K071872 | 000 |
| 07290109950761 | K071872 | 000 |
| 07290109952161 | K071872 | 000 |
| 07290109952154 | K071872 | 000 |
| 07290109951560 | K071872 | 000 |
| 07290109951553 | K071872 | 000 |
| 07290109951546 | K071872 | 000 |
| 07290109951539 | K071872 | 000 |
| 07290109951447 | K071872 | 000 |
| 07290109951430 | K071872 | 000 |
| 07290109951423 | K071872 | 000 |
| 07290109951348 | K071872 | 000 |
| 07290109951317 | K071872 | 000 |
| 07290109951294 | K071872 | 000 |
| 17290109952151 | K071872 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VELASHAPE 77288690 3526527 Live/Registered |
SYNERON CANADA CORPORATION 2007-09-25 |