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

K152205 is an FDA 510(k) premarket notification submitted by Heidelberg Engineering GmbH for the device "Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor". The FDA issued a decision of Substantially Equivalent on May 6, 2016. 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.