Cleared Traditional

CIRRUS? HD-OCT Model 6000

K233933 · Carl Zeiss Meditec, Inc. · Ophthalmic

May 2024

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K233933 is an FDA 510(k) clearance for the CIRRUS? HD-OCT Model 6000, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Carl Zeiss Meditec, Inc. (Dublic, US). The FDA issued a Cleared decision on May 17, 2024, 155 days after receiving the submission on December 14, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K233933 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 14, 2023
Decision Date	May 17, 2024
Days to Decision	155 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.