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
| Device Type ID | 4032 |
| Device Name | System, Assisted Reproduction Laser |
| Regulation Description | Assisted Reproduction Laser System. |
| Regulation Medical Specialty | Obstetrics/Gynecology |
| Review Panel | Obstetrics/Gynecology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Obstetrics And Gynecology Devices Branch (OGDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 884.6200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MRX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4032 |
| Device | System, Assisted Reproduction Laser |
| Product Code | MRX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Assisted Reproduction Laser System. |
| CFR Regulation Number | 884.6200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RESEARCH INSTRUMENTS LIMITED | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RESEARCH INSTRUMENTS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |