HOH — Spectacle, Operating (Loupe), Ophthalmic Class I

FDA Device Classification

FDA product code HOH covers "Spectacle, Operating (Loupe), Ophthalmic", a Class I medical device regulated under 21 CFR 886.4770. Submissions are reviewed by the Ophthalmic panel. At least 3 recent 510(k) clearances have been granted under this product code.