The following data is part of a premarket notification filed by Vitrolife Gmbh with the FDA for Lasershot M, Navilase.
| Device ID | K192008 |
| 510k Number | K192008 |
| Device Name: | LaserShot M, NaviLase |
| Classification | System, Assisted Reproduction Laser |
| Applicant | Vitrolife GmbH Dr. -Pauling-Str.9 Bruckberg, DE 84079 |
| Contact | Susanne Schweitzer |
| Correspondent | Susanne Schweitzer Vitrolife GmbH Dr. -Pauling-Str.9 Bruckberg, DE 84079 |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260604170028 | K192008 | 000 |
| 04260604170011 | K192008 | 000 |