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

Nidek Co., Ltd.
Free shipping on orders over $99 · 30-day returns
OPHTHALMOSCOPE F-10 is an FDA 510(k)-cleared medical device (K072259) manufactured by Nidek Co., Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 5, 2008. Regulation: 8.