510(k) Report

FDA product code · Ophthalmic

Topographer, Corneal, Battery Powered

NOGClass I21 CFR 886.1350510(k) exempt0 decisions0 recalls

FDA lists NOG as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 0 FDA decisions. No recall names this code.

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Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026 Download the data (CSV)

FIG. A — Illustration, ophthalmic panel

Twenty years of NOG at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FIG. 1 — NOG by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NOG? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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