The following data is part of a premarket notification filed by Sie Ag, Surgical Instrument Engineering with the FDA for Femto Ldv Z8 Femtosecond Surgical Laser.
| Device ID | K213559 |
| 510k Number | K213559 |
| Device Name: | FEMTO LDV Z8 Femtosecond Surgical Laser |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | SIE AG, Surgical Instrument Engineering Allmendstrasse 11 Port, CH Ch-2502 |
| Contact | Frank Ziemer |
| Correspondent | Kevin Walls Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, CO 80127 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-04 |
| Decision Date | 2022-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167750573 | K213559 | 000 |