# Medical Devices; Obstetrical and Gynecological Devices; Classification of the Assisted Reproduction Laser System
> **Food and Drug Administration** · Final rule. · Published 2004-12-28 · Effective 2005-01-27 · 69 FR 77623
## Document
- **Document number:** 04-28251
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 77623
- **CFR reference:** 21 CFR 884
- **Publication date:** 2004-12-28
- **Effective date:** 2005-01-27
- **HHS docket:** Docket No. 2004N-0530
## Abstract

The Food and Drug Administration (FDA) is classifying the assisted reproduction laser system into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems." The agency is classifying this device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of the guidance document that is the special control for this device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/12/28/04-28251/medical-devices-obstetrical-and-gynecological-devices-classification-of-the-assisted-reproduction)
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