510(k) K101223

SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA by Heidelberg Engineering — Product Code OBO

K101223 is an FDA 510(k) premarket notification submitted by Heidelberg Engineering for the device "SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA". The FDA issued a decision of Substantially Equivalent on October 1, 2010. The device falls under product code OBO (Tomography, Optical Coherence), a Class II device regulated under 21 CFR 886.1570. Heidelberg Engineering has at least 10 other 510(k) clearances on record.