FDA product code MRX: System, Assisted Reproduction Laser
MRX is the FDA product code for system, assisted reproduction laser. It is a Class II device, regulated under 21 CFR 884.6200 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 10 510(k) submissions under MRX, 1 in the last five years, from 6 different applicants. The average 510(k) review took 213 days (median 250); 260 days on average over the last three years. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | System, Assisted Reproduction Laser |
| Device class | Class II |
| Regulation | 21 CFR 884.6200 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for MRX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 240 |
| 2021 | 1 | 326 |
| 2026 | 1 | 260 |
Compare with all 510(k) review times · Search every MRX clearance
Top MRX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Research Instruments , Ltd. | 3 | 2015-02-18 |
| Hamilton Thorne, Inc. | 2 | 2021-07-02 |
| Hamilton Thorne Biosciences | 2 | 2007-04-24 |
| Hua Yue Medical Technology Co., Ltd. | 1 | 2026-06-17 |
| Vitrolife GmbH | 1 | 2020-03-25 |
1 more applicants have MRX clearances. See the full list in Caduvo.
Most recent MRX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253333 | Hua Yue Medical Technology Co., Ltd. | Assisted Reproduction Laser System (Model ILS-400M) | 2026-06-17 | 260 |
| K202241 | Hamilton Thorne, Inc. | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | 2021-07-02 | 326 |
| K192008 | Vitrolife GmbH | LaserShot M, NaviLase | 2020-03-25 | 240 |
| K141434 | Research Instruments , Ltd. | SATURN 5 LASER | 2015-02-18 | 264 |
| K120055 | Hamilton Thorne, Inc. | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS | 2012-04-24 | 106 |
Recalls for MRX devices
openFDA lists no recalls for product code MRX.
Frequently asked questions
What is FDA product code MRX?
MRX is the FDA product code for system, assisted reproduction laser. It is a Class II device, regulated under 21 CFR 884.6200 and reviewed by the Obstetrics and Gynecology panel.
What device class is MRX?
Class II, regulation 21 CFR 884.6200. Typical premarket route: 510(k).
How long does a 510(k) take for product code MRX?
Across 10 cleared submissions the average was 213 days from receipt to decision (median 250).
Which companies have the most MRX clearances?
Research Instruments , Ltd. (3); Hamilton Thorne, Inc. (2); Hamilton Thorne Biosciences (2); Hua Yue Medical Technology Co., Ltd. (1); Vitrolife GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MRX
- Run a recall and safety report across every MRX manufacturer
- Watch product code MRX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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