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Automated Ophthalmics Softips Tonopen Tip Cover

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.

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