FDA 510(k) Applications for Medical Device Product Code "MRX"
(System, Assisted Reproduction Laser)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| DEN040009 | HAMILTON THORNE BIOSCIENCES | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) | 11/04/2004 |
| K063636 | HAMILTON THORNE BIOSCIENCES | ZILOS-TK | 04/24/2007 |
| K050768 | HAMILTON THORNE BIOSCIENCES | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | 04/28/2005 |
| K120055 | HAMILTON THORNE, INC. | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS | 04/24/2012 |
| K202241 | Hamilton Thorne, Inc. | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | 07/02/2021 |
| K062524 | MINITUBE OF AMERICA, INC | OCTAX LASER SHOT SYSTEM | 12/15/2006 |
| K060764 | RESEARCH INSTRUMENTS LTD. | SATURN 3 LASER SYSTEM | 03/12/2007 |
| K141434 | RESEARCH INSTRUMENTS LTD. | SATURN 5 LASER | 02/18/2015 |
| K083208 | RESEARCH INSTRUMENTS LTD. | SATURN ACTIVE LASER SYSTEM | 08/25/2009 |
| K192008 | Vitrolife GmbH | LaserShot M, NaviLase | 03/25/2020 |
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