Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor— 510(k) K172649

Name: FDA 510(k) clearance K172649
Creator: U.S. Food and Drug Administration
Published: 2017-11-01

Substantially Equivalent

Heidelberg Engineering GmbH

FDA 510(k) clearance K172649 for Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor, Substantially Equivalent on 2017-11-01. Applicant: Heidelberg Engineering GmbH. Device class: 2.

Clearance details

Applicant: Heidelberg Engineering GmbH
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2017-09-05
Decision date: 2017-11-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Heidelberg, DE

Download summary PDF View on FDA.gov ↗

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