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K Number
K971078
Device Name
HYDROBRUSH (TM) KERATOME
Manufacturer
MEDJET, INC.
Date Cleared
1998-01-23

(305 days)

Product Code
HQS
Regulation Number
886.4070
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
Predicate For
K991124
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Any condition which requires removal of the epithelium from the cornea.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the HydroBrush™ Keratome. It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

The letter is a regulatory approval document, not a scientific study report. Therefore, I cannot fulfill your request with the information provided.

§ 886.4070 Powered corneal burr.

(a)
Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.