510(k) K172649

Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor by Heidelberg Engineering GmbH — Product Code OBO

K172649 is an FDA 510(k) premarket notification submitted by Heidelberg Engineering GmbH for the device "Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor". The FDA issued a decision of Substantially Equivalent on November 1, 2017. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Heidelberg Engineering GmbH has at least 10 other 510(k) clearances on record.