Cleared Traditional

Spectralis HRA+OCT and variants with OCT Angiography Module

K181594 · Heidelberg Engineering GmbH · Ophthalmic

Sep 2018

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K181594 is an FDA 510(k) clearance for the Spectralis HRA+OCT and variants with OCT Angiography Module, 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 September 13, 2018, 87 days after receiving the submission on June 18, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K181594 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2018
Decision Date	September 13, 2018
Days to Decision	87 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.