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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 886 - Ophthalmic Devices |
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Subpart E - Surgical Devices |
§ 886.4070 - Powered corneal burr.
Latest version.
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§ 886.4070 Powered corneal burr.
(a) Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.
(b) Classification. Class I (general controls). When intended only for rust ring removal, the The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2321, Jan. 14, 2000; 84 FR 71817, Dec. 30, 2019]