Cleared Traditional

Tomey Cornea/Anterior Segment OCT CASIA2

K213265 · Tomey Corporation · Ophthalmic

Apr 2022

Decision

209d

Days

Class 2

Risk

About This 510(k) Submission

K213265 is an FDA 510(k) clearance for the Tomey Cornea/Anterior Segment OCT CASIA2, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Tomey Corporation (Nishi-Ku, JP). The FDA issued a Cleared decision on April 27, 2022, 209 days after receiving the submission on September 30, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K213265 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	OBO — Tomography, Optical Coherence
Device Class	Class II — 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.