MRX
11 FDA 510(k) clearances · Product code
240 daysmedian time to decision
326 days90th percentile
11clearances measured
FDA profile
- Official device name
- System, Assisted Reproduction Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6200
- Medical specialty
- Obstetrics/Gynecology
- FDA 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Assisted Reproduction Laser System (Model ILS-400M) (K253333) | Hua Yue Medical Technology Co., Ltd. | 2026-06-17 |
| LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (K202241) | Hamilton Thorne, Inc. | 2021-07-02 |
| LaserShot M, NaviLase (K192008) | Vitrolife GmbH | 2020-03-25 |
| SATURN 5 LASER (K141434) | Research Instruments , Ltd. | 2015-02-18 |
| HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS (K120055) | Hamilton Thorne, Inc. | 2012-04-24 |
| SATURN ACTIVE LASER SYSTEM (K083208) | Research Instruments , Ltd. | 2009-08-25 |
| ZILOS-TK (K063636) | Hamilton Thorne Biosciences | 2007-04-24 |
| SATURN 3 LASER SYSTEM (K060764) | Research Instruments , Ltd. | 2007-03-12 |
| OCTAX LASER SHOT SYSTEM (K062524) | Minitube of America, Inc. | 2006-12-15 |
| ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 (K050768) | Hamilton Thorne Biosciences | 2005-04-28 |
| HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) (DEN040009) | Hamilton Thorne Biosciences | 2004-11-04 |
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Every clearance here is in the API, with alerts when new ones post.