Cleared Traditional

RESCAN 700, CALLISTO eye

K180229 · Carl Zeiss Meditec, AG · Ophthalmic

Jan 2019

Decision

350d

Days

Class 2

Risk

About This 510(k) Submission

K180229 is an FDA 510(k) clearance for the RESCAN 700, CALLISTO eye, 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 January 11, 2019, 350 days after receiving the submission on January 26, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K180229 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 26, 2018
Decision Date	January 11, 2019
Days to Decision	350 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.