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510(k) K152205

Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor by Heidelberg Engineering GmbH — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 6, 2016
Date Received: August 6, 2015
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tomography, Optical Coherence
Device Class: Class II
Regulation Number: 886.1570
Review Panel: OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

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