MRX · System, Assisted Reproduction Laser
Obstetrics/Gynecology · 21 CFR 884.6200 · Class 2
Overview
| Product Code | MRX |
|---|---|
| Device Name | System, Assisted Reproduction Laser |
| Regulation | 21 CFR 884.6200 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
Identification
The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. | Jul 2, 2021 | SESE |
| K192008 | LaserShot M, NaviLase | Vitrolife GmbH | Mar 25, 2020 | SESE |
| K141434 | SATURN 5 LASER | Research Instruments , Ltd. | Feb 18, 2015 | SESE |
| K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS | Hamilton Thorne, Inc. | Apr 24, 2012 | SESE |
| K083208 | SATURN ACTIVE LASER SYSTEM | Research Instruments , Ltd. | Aug 25, 2009 | SESE |
| K063636 | ZILOS-TK | Hamilton Thorne Biosciences | Apr 24, 2007 | SESE |
| K060764 | SATURN 3 LASER SYSTEM | Research Instruments , Ltd. | Mar 12, 2007 | SESE |
| K062524 | OCTAX LASER SHOT SYSTEM | Minitube of America, Inc. | Dec 15, 2006 | SESE |
| K050768 | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | Hamilton Thorne Biosciences | Apr 28, 2005 | SESE |
| DEN040009 | HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) | Hamilton Thorne Biosciences | Nov 4, 2004 | DENG |
Top Applicants
- Hamilton Thorne Biosciences — 3 clearances
- Research Instruments , Ltd. — 3 clearances
- Hamilton Thorne, Inc. — 2 clearances
- Minitube of America, Inc. — 1 clearance
- Vitrolife GmbH — 1 clearance
