
Bioptigen, Inc.
Free shipping on orders over $99 · 30-day returns
BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K063343) manufactured by Bioptigen, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 12, 2006. Regulation: 8.