Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Heidelberg Engineering
Free shipping on orders over $99 · 30-day returns
SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA is an FDA 510(k)-cleared medical device (K101223) manufactured by Heidelberg Engineering. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 30, 2010. Regulation: 8.