Cleared Traditional

RESCAN 700

K233421 · Carl Zeiss Meditec, AG · Ophthalmic

Mar 2024

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K233421 is an FDA 510(k) clearance for the RESCAN 700, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on March 8, 2024, 150 days after receiving the submission on October 10, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K233421 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 2023
Decision Date	March 08, 2024
Days to Decision	150 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.