The following data is part of a premarket notification filed by Syneron, Ltd. with the FDA for Eplus Skin Treatment System.
| Device ID | K113868 |
| 510k Number | K113868 |
| Device Name: | EPLUS SKIN TREATMENT SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERON, LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Contact | Yoram Levy |
| Correspondent | Yoram Levy SYNERON, LTD. 31 HAAVODA ST. Binyamina, IL 30500 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-12-30 |
| Decision Date | 2012-06-11 |
| Summary: | summary |