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K Number
K971134
Device Name
VISTA EYESHOWER
Manufacturer
JOHN BRANCH
Date Cleared
1997-11-04

(221 days)

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

The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye to help relieve discomfort caused by foreign material, air pollutants, or chlorinated water.

For Over-The-Counter use.

Device Description

The Vista EYESHOWER is a single-use, disposable device intended for use with Iriqate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye.

AI/ML Overview

The provided documents are FDA 510(k) letters for the Vista EYESHOWER, a single-use, disposable device for eye irrigation. These letters confirm the device's substantial equivalence to a predicate device but do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the given input. The documents are purely administrative communications regarding regulatory clearance.

N/A