HKN — Refractor, Manual, Non-Powered, Including Phoropter Class I

FDA Device Classification

FDA product code HKN covers "Refractor, Manual, Non-Powered, Including Phoropter", a Class I medical device regulated under 21 CFR 886.1770. Submissions are reviewed by the Ophthalmic panel. At least 3 recent 510(k) clearances have been granted under this product code.