The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Modification To Velasmooth, Shaper.
| Device ID | K070092 |
| 510k Number | K070092 |
| Device Name: | MODIFICATION TO VELASMOOTH, SHAPER |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, IL 20692 |
| Contact | Yoni Iger |
| Correspondent | Yoni Iger SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, 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 | 2007-01-10 |
| Decision Date | 2007-07-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109951966 | K070092 | 000 |
| 07290109950471 | K070092 | 000 |
| 07290109950488 | K070092 | 000 |
| 07290109950532 | K070092 | 000 |
| 07290109950549 | K070092 | 000 |
| 07290109950556 | K070092 | 000 |
| 07290109950563 | K070092 | 000 |
| 07290109950570 | K070092 | 000 |
| 07290109950587 | K070092 | 000 |
| 07290109950594 | K070092 | 000 |
| 07290109950600 | K070092 | 000 |
| 07290109951300 | K070092 | 000 |
| 07290109951461 | K070092 | 000 |
| 07290109951478 | K070092 | 000 |
| 07290109951492 | K070092 | 000 |
| 07290109951508 | K070092 | 000 |
| 07290109950464 | K070092 | 000 |