Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart G — Assisted Reproduction Devices](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices) → [21 CFR 884.6200](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6200) → MRX — System, Assisted Reproduction Laser

# MRX · System, Assisted Reproduction Laser

_Obstetrics/Gynecology · 21 CFR 884.6200 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX

## Overview

- **Product Code:** MRX
- **Device Name:** System, Assisted Reproduction Laser
- **Regulation:** [21 CFR 884.6200](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/884.6200)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)

## 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](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K202241.md) | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | Hamilton Thorne, Inc. | Jul 2, 2021 | SESE |
| [K192008](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K192008.md) | LaserShot M, NaviLase | Vitrolife GmbH | Mar 25, 2020 | SESE |
| [K141434](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K141434.md) | SATURN 5 LASER | Research Instruments , Ltd. | Feb 18, 2015 | SESE |
| [K120055](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K120055.md) | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK  HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS | Hamilton Thorne, Inc. | Apr 24, 2012 | SESE |
| [K083208](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K083208.md) | SATURN ACTIVE LASER SYSTEM | Research Instruments , Ltd. | Aug 25, 2009 | SESE |
| [K063636](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K063636.md) | ZILOS-TK | Hamilton Thorne Biosciences | Apr 24, 2007 | SESE |
| [K060764](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K060764.md) | SATURN 3 LASER SYSTEM | Research Instruments , Ltd. | Mar 12, 2007 | SESE |
| [K062524](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K062524.md) | OCTAX LASER SHOT SYSTEM | Minitube of America, Inc. | Dec 15, 2006 | SESE |
| [K050768](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/K050768.md) | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 | Hamilton Thorne Biosciences | Apr 28, 2005 | SESE |
| [DEN040009](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/DEN040009.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX)

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