The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Aurora Ds, Ds Applicator.
| Device ID | K050796 |
| 510k Number | K050796 |
| Device Name: | AURORA DS, DS APPLICATOR |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman SYNERON MEDICAL LTD. P.O. BOX 550 INDUSTRIAL ZONE Yokneam Illit, IL 20692 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-29 |
| Decision Date | 2005-04-12 |
| Summary: | summary |