Cleared Special

Spectralis HRA+OCT and Variants

K192391 · Heidelberg Engineering GmbH · Ophthalmic

Sep 2019

Decision

23d

Days

Class 2

Risk

About This 510(k) Submission

K192391 is an FDA 510(k) clearance for the Spectralis HRA+OCT and Variants, 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 26, 2019, 23 days after receiving the submission on September 3, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1570.

Submission Details

510(k) Number	K192391 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2019
Decision Date	September 26, 2019
Days to Decision	23 days
Submission Type	Special
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.