Ophthalmic

HRF · Engine, Trephine, Accessories, Battery-Powered

Ophthalmic · 21 CFR 886.4070 · Class 1

Overview

Product CodeHRF
Device NameEngine, Trephine, Accessories, Battery-Powered
Regulation21 CFR 886.4070
Device ClassClass 1
Review PanelOphthalmic

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.

Classification Rationale

Class I (general controls). 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.

Cleared Devices (0)

No cleared devices on record.

Innolitics

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