# Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level Laser System for Aesthetic Use
> **Food and Drug Administration** · Final rule. · Published 2011-04-14 · Effective 2011-05-16 · 76 FR 20840
## Document
- **Document number:** 2011-8944
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 20840
- **CFR reference:** 21 CFR 878
- **Publication date:** 2011-04-14
- **Effective date:** 2011-05-16
- **HHS docket:** Docket No. FDA-2011-N-0188
## Abstract

The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled "Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use." The Agency is classifying the 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 announcing the availability of a guidance document that will serve as the special control for this device type.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/04/14/2011-8944/medical-devices-general-and-plastic-surgery-devices-classification-of-the-low-level-laser-system-for)
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