VELASHAPE
Massager, Vacuum, Light Induced Heating
SYNERON MEDICAL LTD.
The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Velashape.
Pre-market Notification Details
| Device ID | K122579 |
| 510k Number | K122579 |
| Device Name: | VELASHAPE |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | SYNERON MEDICAL LTD. INDUSTRIAL ZONE TAVOR BLDG P.O.B 550 Yokneam, Illit, IL 20692 |
| Contact | Sam Wade |
| Correspondent | Sam Wade SYNERON MEDICAL LTD. INDUSTRIAL ZONE TAVOR BLDG P.O.B 550 Yokneam, Illit, IL 20692 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2012-09-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 37290109950427 | K122579 | 000 |
| 07290109950808 | K122579 | 000 |
| 07290109950433 | K122579 | 000 |
| 07290109950426 | K122579 | 000 |
| 07290109950419 | K122579 | 000 |
| 07290109950402 | K122579 | 000 |
| 07290109950396 | K122579 | 000 |
| 00817495024578 | K122579 | 000 |
| 00817495024462 | K122579 | 000 |
| 00817495024066 | K122579 | 000 |
| 00817495023861 | K122579 | 000 |
| 07290109951546 | K122579 | 000 |
| 07290109951751 | K122579 | 000 |
| 17290109952212 | K122579 | 000 |
| 17290109950430 | K122579 | 000 |
| 17290109950423 | K122579 | 000 |
| 17290109950416 | K122579 | 000 |
| 17290109952694 | K122579 | 000 |
| 07290109952437 | K122579 | 000 |
| 07290109952215 | K122579 | 000 |
| 07290109952031 | K122579 | 000 |
| 07290109952024 | K122579 | 000 |
| 07290109951867 | K122579 | 000 |
| 00817495022727 | K122579 | 000 |
Trademark Results [VELASHAPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VELASHAPE 77288690 3526527 Live/Registered |
SYNERON CANADA CORPORATION 2007-09-25 |
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