The following data is part of a premarket notification filed by Sie Ag,surgical Instrument Engineering with the FDA for Femto Ldv Z8 Surgical Laser.
| Device ID | K150323 |
| 510k Number | K150323 |
| Device Name: | FEMTO LDV Z8 Surgical Laser |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | SIE AG,Surgical Instrument Engineering Allmendstrasse 11 Port, CH Ch2562 |
| 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 | 2015-02-09 |
| Decision Date | 2015-10-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167751167 | K150323 | 000 |
| 07640167751341 | K150323 | 000 |
| 07640167751358 | K150323 | 000 |
| 07640167751365 | K150323 | 000 |
| 07640167751372 | K150323 | 000 |
| 07640167751389 | K150323 | 000 |
| 07640167750016 | K150323 | 000 |
| 07640167751051 | K150323 | 000 |
| 07640167751068 | K150323 | 000 |
| 07640167751082 | K150323 | 000 |
| 07640167751143 | K150323 | 000 |
| 07640167751129 | K150323 | 000 |
| 07640167751105 | K150323 | 000 |
| 07640167751334 | K150323 | 000 |