# Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System
> **Food and Drug Administration** · Final rule. · Published 2011-08-19 · Effective 2011-09-19 · 76 FR 51876
## Document
- **Document number:** 2011-21195
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 76 FR 51876
- **CFR reference:** 21 CFR 886
- **Publication date:** 2011-08-19
- **Effective date:** 2011-09-19
- **HHS docket:** Docket No. FDA-2011-M-0570
## Abstract

The Food and Drug Administration (FDA) is classifying the eyelid thermal pulsation system into class II (special controls). 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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2011/08/19/2011-21195/medical-devices-ophthalmic-devices-classification-of-the-eyelid-thermal-pulsation-system)
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