K192008 is an FDA 510(k) clearance for the LaserShot M, NaviLase. This device is classified as a System, Assisted Reproduction Laser (Class II - Special Controls, product code MRX).
Submitted by Vitrolife GmbH (Bruckberg, DE). The FDA issued a Cleared decision on March 25, 2020, 240 days after receiving the submission on July 29, 2019.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.6200. This System Is Inteded To Be Used To Drill A Small Tangential Hole In Or To Thin The Zona Pellucida Of The Embryo In Selected In Vitro Fertilization Patients With Otherwise Poor Prognois For Successful Pregnancy Outcome, Such As Advanced Maternal Age, Prior Failed In Vitro Fertilization Procedures, Cryopreserved Embryos, Or Abnormal Zona Pellucida Morphology..
| 510(k) Number | K192008 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2019 |
| Decision Date | March 25, 2020 |
| Days to Decision | 240 days |
| Submission Type | Abbreviated |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | MRX - System, Assisted Reproduction Laser |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.6200 |
| Definition | This System Is Inteded To Be Used To Drill A Small Tangential Hole In Or To Thin The Zona Pellucida Of The Embryo In Selected In Vitro Fertilization Patients With Otherwise Poor Prognois For Successful Pregnancy Outcome, Such As Advanced Maternal Age, Prior Failed In Vitro Fertilization Procedures, Cryopreserved Embryos, Or Abnormal Zona Pellucida Morphology. |