Cleared Special

K111710 - FULL AUTO TONOMETER MODEL TX-20 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K111710 · Canon Inc. -Medical Equipment Group · Ophthalmic device
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Sep 2011
Decision
92d
Days
Class 2
Risk

K111710 is an FDA 510(k) clearance for the FULL AUTO TONOMETER MODEL TX-20. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Canon Inc. -Medical Equipment Group (Tachikawa-Shi, Tokyo, JP). The FDA issued a Cleared decision on September 20, 2011 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Canon Inc. -Medical Equipment Group devices

Submission Details

510(k) Number K111710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2011
Decision Date September 20, 2011
Days to Decision 92 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 110d · This submission: 92d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.