Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System
fda-device · Food and Drug Administration · Rule · Published 2011-08-19 · Effective 2011-09-19 · 76 FR 51876
Document
Document number
2011-21195
Federal Register citation
76 FR 51876
CFR reference
21 CFR 886
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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.