Name: Predicase
Price: 199 USD

K-number	K253039
Device name	AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
Applicant	Topcon Corporation
Product code	HKX
Device class	Class II
Decision date	Nov 7, 2025
Decision	Substantially Equivalent
Regulation	886.1930

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

Everything you need for a 510(k) submission. Nothing you don't.