LogoFDA 510(k) Search
K Number
K984537
Device Name
KERATOME SYSTEM, MODEL K3000
Manufacturer
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
Date Cleared
1999-05-14

(144 days)

Product Code
HMY
Regulation Number
886.4370
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device (Keratome System, Model K3000). It acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

However, the provided text DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The letter is purely an FDA clearance notice, not a study summary.

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.