The following data is part of a premarket notification filed by El.en. S.p.a with the FDA for Deka Smartxide Laser System.
| Device ID | K133895 |
| 510k Number | K133895 |
| Device Name: | DEKA SMARTXIDE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | EL.EN. S.P.A 2 JORDAN ROAD Hopkinton, MA 01748 |
| Contact | George Cho |
| Correspondent | George Cho EL.EN. S.P.A 2 JORDAN ROAD Hopkinton, MA 01748 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-20 |
| Decision Date | 2014-09-05 |
| Summary: | summary |