AUTOMATED OPHTHALMICS SOFTIPS

• K Number: K992998
• Device Name: AUTOMATED OPHTHALMICS SOFTIPS
• Manufacturer: AUTOMATED OPHTHALMICS, INC.
• Date Cleared: 2000-01-10 ( 125 days)
• Product Code: HKY
• Regulation Number: 886.1930
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

Not Found

Device Description

Automated Ophthalmics Softips Tonopen Tip Cover

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device called "Automated Ophthalmics Softips Tonopen Tip Cover". It primarily concerns regulatory approval and does not contain information about acceptance criteria, device performance, or specific studies that prove the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on its substantial equivalence to a predicate device, rather than through a study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from this document.

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.