Cleared Traditional

Anterion

K211817 · Heidelberg Engineering GmbH · Ophthalmic

Nov 2021

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K211817 is an FDA 510(k) clearance for the Anterion, a Tomography, Optical Coherence (Class II — Special Controls, product code OBO), submitted by Heidelberg Engineering GmbH (Heidelberg, DE). The FDA issued a Cleared decision on November 5, 2021, 147 days after receiving the submission on June 11, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K211817 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 11, 2021
Decision Date	November 05, 2021
Days to Decision	147 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.