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510(k) Data Aggregation

K Number

Device Name

ACCUJECT Injector Set 2.1-1P (LP604590)

Manufacturer

Date Cleared

2025-09-16

(35 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The ACCUJECT IOL Injector is indicated to fold and insert BVI IOLs approved for use with this injector in the human eye.

Device Description

The ACCUJECT Injector Set is an assembled injection system that is single use with a silicone cushion tip that is used to push forward and insert the IOL that has been placed in a single use cartridge into the eye. As the lens enters the tip it is folded and compressed.

AI/ML Overview

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