K-number	K213265
Device name	Tomey Cornea/Anterior Segment OCT CASIA2
Applicant	Tomey Corporation
Product code	OBO
Device class	Class II
Decision date	Apr 27, 2022
Decision	Substantially Equivalent
Regulation	886.1570

AI Summary

AI extraction for this record is queued and will appear within 24 hours. View full FDA record →

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 →

Building an AI or ML-enabled device? Predicate search, PCCP tracking, and AI-specific FDA intelligence — built exclusively for AI/ML devices. Try AIFDA Intel →

Tomey Cornea/Anterior Segment OCT CASIA2

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