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K Number
K972252
Device Name
VISTA UNIVERSAL HANDPIECE
Manufacturer
ODYSSEY TECHNOLOGIES, INC.
Date Cleared
1997-07-29

(43 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

For use in cataract surgery to disrupt a cataract with ultrasound through emulsification and extract the cataract.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a medical device (Odyssey Technologies Vista Universal Handpiece) and an "Indications For Use Statement." It does not contain information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications as requested.

Therefore, I cannot provide the information in the requested format based on the given text. The document is primarily a regulatory approval notice and a statement of the intended use of the device, not a technical report detailing performance studies.

§ 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.