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K Number
K003638
Device Name
MOJAVE CATARACT EXTRACTION SYSTEM
Manufacturer
ALLERGAN, INC.
Date Cleared
2001-02-13

(81 days)

Product Code
HQC
Regulation Number
886.4670
Type
Abbreviated
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.4670 Phacofragmentation system.

(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.