Panels › Obstetrics/Gynecology › Product code MRX · Class 2
System, Assisted Reproduction Laser
Regulation 884.6200
1510(k)s in 12 months (11 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MRX
| Company | 510(k)s | Recalls |
|---|---|---|
| Hamilton Thorne Biosciences | 3 | 0 |
| Research Instruments , Ltd. | 3 | 0 |
| Hamilton Thorne, Inc. | 2 | 0 |
| Hua Yue Medical Technology Co., Ltd. | 1 | 0 |
| Minitube of America, Inc. | 1 | 0 |
| Vitrolife GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 17, 2026 | K253333 | Assisted Reproduction Laser System (Model ILS-400M) Hua Yue Medical Technology Co., Ltd., CN | MRX |
| Jul 2, 2021 | K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) Hamilton Thorne, Inc. | MRX |
| Mar 25, 2020 | K192008 | LaserShot M, NaviLase Vitrolife GmbH, DE | MRX |
| Feb 18, 2015 | K141434 | SATURN 5 LASER Research Instruments , Ltd., GB | MRX |
| Apr 24, 2012 | K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS Hamilton Thorne, Inc. | MRX |
| Aug 25, 2009 | K083208 | SATURN ACTIVE LASER SYSTEM Research Instruments , Ltd., GB | MRX |
| Apr 24, 2007 | K063636 | ZILOS-TK Hamilton Thorne Biosciences | MRX |
| Mar 12, 2007 | K060764 | SATURN 3 LASER SYSTEM Research Instruments , Ltd. | MRX |
| Dec 15, 2006 | K062524 | OCTAX LASER SHOT SYSTEM Minitube of America, Inc. | MRX |
| Apr 28, 2005 | K050768 | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 Hamilton Thorne Biosciences | MRX |
| Nov 4, 2004 | DEN040009 | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) Hamilton Thorne Biosciences | MRX |
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