Cleared Traditional

K213265 - Tomey Cornea/Anterior Segment OCT CASIA2 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K213265 · Tomey Corporation · Ophthalmic device
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Apr 2022
Decision
209d
Days
Class 2
Risk

K213265 is an FDA 510(k) clearance for the Tomey Cornea/Anterior Segment OCT CASIA2. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Tomey Corporation (Nishi-Ku, JP). The FDA issued a Cleared decision on April 27, 2022 after a review of 209 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Tomey Corporation devices

Submission Details

510(k) Number K213265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2021
Decision Date April 27, 2022
Days to Decision 209 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 110d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Ora, Inc.
Roger Albright

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT04486976 Completed Interventional Industry-sponsored

Comparative Study of the Cornea/Anterior Segment OCT CASIA2 and the RTVue XR OCT Avanti With AngioVue Software

134
Patients (actual)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Glaucoma; Cataract
Study design Crossover
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Tomey Corporation (industry)
Started 2020-06-27 → Primary completion 2021-03-05
Primary outcome
Agreement of Corneal thickness (μm) measurement for Cornea/Anterior Segment OCT CASIA2 and Optovue RTVue XR Avanti OCT
Secondary outcome
Adverse Events
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 64
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K213265.
UNITY DX (UDX)
K252633 · Cylite Pty. , Ltd. · Dec 2025
Tomey Cornea/Anterior Segment OCT (CASIA2)
K250553 · Tomey Corporation · Jul 2025
SPECTRALIS HRA+OCT and variants
K250868 · Heidelberg Engineering GmbH · May 2025
Anterion
K240924 · Heidelberg Engineering GmbH · Dec 2024
SPECTRALIS with Flex Module
K241163 · Heidelberg Engineering GmbH · Oct 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · Topcon Corporation · Jul 2024