The following data is part of a premarket notification filed by Syneron Medical Ltd with the FDA for Contour I V3.1 System.
| Device ID | K133238 |
| 510k Number | K133238 |
| Device Name: | CONTOUR I V3.1 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 | 2013-10-21 |
| Decision Date | 2014-04-10 |
| Summary: | summary |