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K Number
K960811
Device Name
PHACOSCOPE
Manufacturer
SAINT JOHN'S PLAZA MEDICAL GROUP
Date Cleared
1996-10-02

(218 days)

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

Provide illumination at surgical site.

Device Description

Phacofragmentation system containing fiber optic light guides directed through fluid channels, and through infusion sleeve.

AI/ML Overview

I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for a medical device (Fiber Optic Phacofragmentation System) and focuses on describing the device, its intended use, and its equivalence to predicate devices, rather than presenting acceptance criteria and study results.

§ 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.