PORTABLE NON-CONTACT TONOMETER, MODEL PT100

• K Number: K013259
• Device Name: PORTABLE NON-CONTACT TONOMETER, MODEL PT100
• Manufacturer: LEICA MICROSYSTEMS, INC. O.I.D.
• Date Cleared: 2002-02-20 ( 142 days)
• Product Code: HKX
• Regulation Number: 886.1930
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the Reichert PT100 Portable Tonometer. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory responsibilities.

Therefore, I cannot provide the requested information based on the provided text.

Regulation Number and Section

§ 886.1930 Tonometer and accessories.

(a)
Identification. A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.(b)
Classification. Class II.