The following data is part of a premarket notification filed by Syneron Beauty Ltd. with the FDA for Me.
| Device ID | K131649 |
| 510k Number | K131649 |
| Device Name: | ME |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | SYNERON BEAUTY LTD. 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SYNERON BEAUTY LTD. 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-05 |
| Decision Date | 2013-12-11 |
| Summary: | summary |