The following data is part of a premarket notification filed by Surgical Instrument Engineering Ag with the FDA for Femto Ldv(tm) Z-generation Femtosecond Surgical Laser.
| Device ID | K131207 |
| 510k Number | K131207 |
| Device Name: | FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER |
| Classification | Laser, Ophthalmic |
| Applicant | SURGICAL INSTRUMENT ENGINEERING AG 33 Golden Eagle Lane Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SURGICAL INSTRUMENT ENGINEERING AG 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-29 |
| Decision Date | 2013-10-09 |
| Summary: | summary |