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K Number
K240169
Device Name
Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
Manufacturer
Bausch and Lomb Incorporated
Date Cleared
2024-07-26

(186 days)

Product Code
HQC,HQE,HQF
Regulation Number
886.4670
Type
Traditional
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.