The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Velasmooth, Shaper.
| Device ID | K050397 |
| 510k Number | K050397 |
| Device Name: | VELASMOOTH, SHAPER |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | SYNERON MEDICAL LTD. 601 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
| Contact | Donald E Segal |
| Correspondent | Donald E Segal SYNERON MEDICAL LTD. 601 PENNSYLVANIA AVE., N.W. Washington, DC 20004 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-16 |
| Decision Date | 2005-06-09 |
| Summary: | summary |