← Product Code [MRX](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX) · DEN040009

# HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) (DEN040009)

_Hamilton Thorne Biosciences · MRX · Nov 4, 2004 · Obstetrics/Gynecology · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/DEN040009

## Device Facts

- **Applicant:** Hamilton Thorne Biosciences
- **Product Code:** [MRX](/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX.md)
- **Decision Date:** Nov 4, 2004
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 884.6200
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

## 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/DEN040009](https://fda.innolitics.com/submissions/OB/subpart-g%E2%80%94assisted-reproduction-devices/MRX/DEN040009)

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