QQQ · Guide And Positioner, Ophthalmic Drug Delivery Device

Ophthalmic · 21 CFR 886.4300 · Class 1

Overview

Product CodeQQQ
Device NameGuide And Positioner, Ophthalmic Drug Delivery Device
Regulation21 CFR 886.4300
Device ClassClass 1
Review PanelOphthalmic

Identification

An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.

Classification Rationale

Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.

Recent Cleared Devices (0 of 0)

No cleared devices on record.

Innolitics

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